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Gastro-Intestinal

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CO33 (CO33 (BATTMAN))

CO33: Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Advanced, Colorectal Adenocarcinoma: The BATTMAN Trial


Complexity Level: 2

Eligibility: MAIN INCLUSION CRITERIA:Participants with unresectable (metastatic or locally advanced) colorectal adenocarcinoma, which is not mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) and is refractory to available agents. ECOG 0 or 1. 18 years of age or older. Measurable or evaluable disease as per RECIST 1.1. MAIN EXCLUSION CRITERIA: History of primary immunodeficiency, solid organ transplant or allogeneic bone marrow transplant. Prior use of immunosuppressive medication within 7 days, with the exception of corticosteroids (intranasal and inhaled) or systemic corticosteriods at physiological doses. Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment within 2 years. Active or uncontrolled intercurrent illness.

Objectives: PRIMARY: To determine the effect on overall survival (OS) of the combination of botensilimab (BOT) and balstilimab (BAL) and best supportive care (BSC) versus BSC only. SECONDARY: To compare between two arms the following: Progression Free Survival, Overall Response Rate, Clinical Benefit Rate, Health Related Quality of Life, Toxicity and Safety, and Health Economics. TERTIARY: Post-hoc correlative analysis exploring the association between a) putative biomarkers in archival tumour specimens and b) with baseline values and changes in putative biomarkers in blood, serum and plasma and clinical benefit between the arms.

Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Planned

Chair: (Canada) Dr. Jonathan Loree, Canadian Cancer Trials Group, Queen's University, (613) 533-6430 Ext. 76816


Planned
PAC5 (SWOG S2408)

A Randomized Phase III Multicentre Trial of Lanreotide for the Prevention of Postoperative Pancreatic Fistula


Complexity Level: 2

Eligibility: Inclusion Criteria: Histologicallty or radiographically confirmed diagnosis of Pancreatic Cnacer or pancreatic lesion with malignant potential, Planned elective distal pancreatectomy within 60 days, participants must be>18, Participants must have a complete documented medical history and physical exam within 28 days prior to registration/randomization, Exclusion Criteria: Participants must not have been treated with SSA within 180 days prior to randomization, Participants must not have been treated with radiation therapy for pancreatic malignancy at any time prior to randomization, Participants must not have been treated with PRRT at any time prior to randomization, Participants must not have a known history of a prior diagnosis of malabsorption syndrome,

Objectives: Primary Oblective: To compare the incidence of postoperative pancreatic fistula (POPF) occuring within 60 days after surgery in participants randomized to receive preoperative lanreotide versus placebo prior to undergoing distal pancreatectomy for biopsy-proven or suspected neoplasm. Secondary Objectives: a. to compare the incidence of ISGPS defined biochemical leak occuring within 60 days after surgery in patients randomized to receive lanreotide Vs Placebo in the subset of participants with drained placed. b. To compare the number of postoperative days in the hospital within 60 days after surgery in participants randomized to receive preoperative lanreotide Vs placebo. c. To compare change frombaseline in cancer specific quality of life at 14 and 60 days after surgery, as measured by the EORTC QLQ-c30 in participants randomized to receive preoperative lanreotide Vs pplacebo.

NCT Registration ID (from clinicaltrials.gov): NCT06807437
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Planned

Chair: (Canada) Dr. Paul Karanicolas, Odette Cancer Centre, (416) 480-4774


Planned
CO32 (CO.32)

A Phase 3 Randomized Trial Of Neoadjuvant Chemotherapy, Excision And Observation versus Chemoradiotherapy For Early Rectal Cancer. The NEO-RT Trial

Testing chemotherapy versus chemotherapy plus radiotherapy prior to surgery for early rectal cancer


Complexity Level: 2

Eligibility: - Histology confirmed invasive, well-moderately differentiated rectal adenocarcinoma, mismatch repair proficient. - MRI Stage cT1 or cT2 (not eligible for transanal surgery alone), cN0, M0 -Medically fit and eligible to undergo TME or TES - At least 18 yo, no contraindications for chemotherapy, adequate normal ogran and marrow function - ECOG 0 or 1 - Acceissble for treatment and follow up, and able and willing to complete QOL, and agree to use highly effective contraception methods (if applicable)

Objectives: Primary Objective: - Compare the complete clinical response (cCR) rate and primary Quality of Life (QOL) endpoint defined as the rate of major low anterior resection syndrome (LARS) at 12 months after restaging between a strategy of induction chemotherapy and chemoradiotherapy followed by TES Secondary Objectives: - Compare TME free survival, DFS, rate of downstaging to ypT0/1N0/X, and toxicity between arms Tertiary Objectives: - correlative studies, RT planning technique outcomes

NCT Registration ID (from clinicaltrials.gov): NCT06205485
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: February 29, 2024

Chair: (Canada) Dr. Carl Brown, St. Paul's Hospital, (604) 806-8711, (USA) Dr. Hagen Kennecke, Providence Portland Medical Centre, (503) 215-5696


Open to Accrual
CRC10 (NRG-GI008)

Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease (CIRCULATE-NORTH AMERICA)

We want to determine what kind of chemotherapy to recommend to patients based on the presence or absence of circulating tumor DNA (ctDNA) after srugery for colon cancer.


Complexity Level: 2

Eligibility: - Patient must be ≥ 18 years old. - Patients must have histologically/pathologically confirmed Stage IIB, IIC or Stage III colon adenocarcinoma with R0 resection accordingly to AJCC 8th edition criteria. - No radiographic evidence of overt metastatic disease within 28 days prior to study entry - The distal extent of the tumor must be ≥ 12 cm from the anal verge - The patient must have had an en bloc complete gross resection of tumor (curative resection). - The resected tumor specimen and a blood specimen from patients with Stage IIIA or Stage IIIB colon cancer must have central testing for ctDNA using the Signatera assay by Natera.

Objectives: - To compare time to DFS event (recurrence, second primary colorectal cancer or death) in ctDNA (-ve) cohort following resection of stage III colon cancer treated with immediate vs delayed (based on serial ctDNA surveillance) chemotherapy. - compare time to DFS event (recurrence, second primary colorectal cancer or death) in ctDNA (+ve) cohort following resection of colon cancer treated with 5-FU (or capecitabine) and oxaliplatin x 6 months or 5-FU, oxaliplatin and irinotecan x 6 months.

NCT Registration ID (from clinicaltrials.gov): NCT05174169
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Open to Accrual
Activation Date: May 04, 2023

Chair: (Canada) Dr. Jonathan Loree, Canadian Cancer Trials Group, Queen's University, (613) 533-6430 Ext. 76816


Open to Accrual
ES3 (NEEDS)

NEoadjuvant chemoradiotherapy for Esophageal squamous cell carcinoma versus Definitive chemoradiotherapy with salvage Surgery as needed (NEEDS Trial)

Assessing whether we can reduce the number of patients who require surgical intervention by limiting operations to only those who are found to need it following chemoradiotherapy.


Complexity Level: 2

Eligibility: - Histopathologically confirmed SCC of the esophagus in locally advanced stages ct1 N+ or ct2-4a any N, M0 - Technically resectable disease Age >= 18 years and <=80 years - ECOG 0 - 1 - Adequate organ function - Women of childbearing potential must have a negative serum or urine pregnancy test

Objectives: Primary - Overall survival (OS) with a minimum follow up of 2 years - Global health-related quality of life (HRQOL) one year after randomization Secondary - HRQOL - Event free survival (EFS) defined as time to relapse, initiation of any anti-tumor therapy beyond study treatments or death - Loco-regional and distant relapse rates - Histopathological response - Health economy - Surgical complications - Treatment-related adverse events and toxicity - Nutritional outcomes including weight development, dysphagia and appetite assessment - Gender stratified analyses of all endpoints - Exploratory analysis for putative tissue and liquid biomarkers for response to RCT and benefit from either of the two treatment strategies

Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Open to Accrual
Activation Date: September 05, 2024

Chair: (Canada) Dr. Jelena Lukovic, University Health Network, (416) 946-4501


Open to Accrual
GA4

A Randomized Phase II Study of Paclitaxel and Ramucirumab +/- Zanidatamab in HER2 Positive Advanced Gastroesophageal Adenocarcinoma

Participants with advanced stomach, gatroesophageal junction or esophageal cancer that is not treatable by surgical removal and which has high amounts of human epidermal growth factor receptor Type 2 (aka HER2) on the surface of their tumour cells, receive the anti-HER2 drug trastuzumab added to chemotherapy as standard of care, with the benefit that the addition of trastuzumab extends their survival. Investigation of other drugs that target HER2 and other cancer surface proteins simultaneously, or that link HER2 with another anti-cancer drug, have not shown benefit for these participants to-date. When these participants experience further growth of their cancer due to resistance, their next option for treatment is a combination of a toxic chemotherapy and a drug which binds to another cancer surface protein known as the vascular endothelial growth factor receptor type 2 (VEGFR2). Zanidatamab is a new type of antibody/drug that targets HER2, but offers the possible benefit over trastuzumab that it can not only bind slightly different versions of HER2, but it can also bind two HER2 receptors simultaneously. This means that zanidatamab may do a better, more efficient job of blocking HER2 receptors and may therefore have better effect in slowing tumour growth, or even causing tumour cell death. Early trials of zanidatamab in patients with stomach and esophageal cancers expressing HER2 have yielded very promising results both in terms of the effect on their cancers as well as the tolerability of zanidatamab. The current phase II study is seeking to determine whether there is sufficient early evidence that adding zanidatamab to the standard of care therapy for those participant who have become resistant to trastuzumab can better slow the growth of their tumours in order to proceed with a definitive, confirmatory phase III study which would be expected to lead to the approval of zanidatamab as standard of care treatment of these participants.


Complexity Level: 2

Eligibility: Patients must: Have histologically or pathologically confirmed gastroesophageal adenocarcinoma with HER2+ overexpression as confirmed by central testing using FDA-approved HER2 assay that is unresectable or metastatic. Have received and failed at lease one prior trastuzumab-containing regimen (combination with platinum chemotherapy) for treatment of metastatic disease. Failure is defined as demonstrated objective disease progression (radiologic). Have presence of measurable or evaluable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1). Have imaging investigations including CT/MRI of chest/abdomen/pelvis or other scans as necessary to document all sites of disease done within 28 days prior to randomization. ECOG performance status of 0 or 1. Have a life expectancy of > 12 weeks at the time of study entry. Adequate cardiac function by ECHO or MUGA defined as EF > 50% Have adequate normal organ and marrow function

Objectives: Primary objective: Progression free survival Secondary objectives: Overall Survival, Objective Response Rate, Toxicity and Safety of Combination Therapy, Quality of Life, Identification and assessment of putative biomarkers of potential benefit in archival tumour specimens and baseline and on-treatment blood, serum and plasma samples, Other exploratory correlative analyses TBD

NCT Registration ID (from clinicaltrials.gov): NCT06043427
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: November 22, 2023

Chair: (Canada) Dr. Elena Elimova, University Health Network, (416) 946-4501 Ext. 2520


Open to Accrual
HE2

A Phase II Study of STRIDE (durvalumab + tremelimumab) with Lenvatinib versus STRIDE Alone in Patients with Unresectable Hepatocellular Carcinoma (SLIDE-HCC)

The purpose of this trial is to compare the usual approach, STRIDE (durvalumab in combination with tremelimumab) systemic therapy alone to using lenvatinib plus the usual approach. Lenvatinib is known to be effective as a treatment option for unresectable HCC. This study will help the researchers discover if the addtition of lenvatinib to STRIDE is better than the usual approach. To decide if it is better, the researchers will be looking to see if the study approach slows or stabilizes the growth of the participants' liver cancer. Toxicity of adding lenvatinib will also be evaluated. The study will be conducted in Canada and Italy.


Complexity Level: 2

Eligibility: Adult patients with intermediate or advanced hepatocellular carcinoma (HCC) that cannot be treated with surgery, who are not eligible for locoregional therapy and have not received prior drug treatment for their liver cancer are eligible for the study. Patients must have Child-Pugh Score class A or B7 based on low albumin (albumin 25-27 g/L) only. Patients will not be included if they are HIV positive or have an active tuberculosis infection, have an autoimmune or inflammatory disorder (some exceptions) or another type of cancer within the last 5 years (some exceptions), have active peptic ulcer disease, gastritis, or who have a condition that causes or increases risk of bleeding more than usual. Patients who have had major surgery in the past month are also excluded.

Objectives: The primary objective is to compare progression-free survival (PFS) between STRIDE (durvalumab + tremelimumab) with lenvatinib versus STRIDE alone in patients with intermediate and advanced hepatocellular carcinoma not amenable to local therapy. Secondary Objectives: •To determine the effect on overall survival (OS) of STRIDE with or without lenvatinib •To assess the toxicity and safety of STRIDE with or without lenvatinib •To determine the effect on objective response rate (ORR) of STRIDE with or without lenvatinib.

NCT Registration ID (from clinicaltrials.gov): NCT06880523
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: May 01, 2025

Chair: (Canada) Dr. Jennifer Knox, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2399, (Canada) Dr. Vincent Tam, Tom Baker Cancer Centre, (403) 521-3706, (Italy) Dr. Marilina Piccirillo, Unita Sperimentazioni Cliniche Istituto per lo


Open to Accrual
NE1 (NE.1)

NET RETREAT: A Phase II Study of 177Lutetium- DOTATATE Retreatment vs. Everolimus in Metastatic/unresectable Midgut NET

The purpose of this study is to find out whether retreatment with Peptide Receptor Radionuclide Therapy (PRRT) using Lutetium 177 dotatate can slow the growth of well-differentiated Grade 1 and Grade 2 metastatic midgut neuroendocine tumours compared to the usual approach of everollimus.


Complexity Level: 2

Eligibility: At least 18 years of age. Metastatic, histologically confirmed Grade 1 or 2 well-differentiated midgut NET with positive Gallium 68 DOTATATE or Copper 64 DOTATATE scan (SUVmax of target lesion is > SUV mean of normal liver parenchyma) within 36 months (within 12 months is preferred). Have received 3 or 4 cycles of PRRT. Have had progression per RECIST 1.1 after prior PRRT and no sooner than 12 months from last scan post initial PRRT completion where either stable disease, partial response, or complete response has been maintained. Have not received intervening therapy. No ongoing toxicity from prior PRRT that is Grade 3 or higher according to CTCAE 5.0. ECOG performance status
Objectives: Primary Objective: Progression-free survival Secondary Objectives: toxicity and safety, overall response rate, overall survival, post progression survival and time to second objective disease progression for crossover patients, quality of life

NCT Registration ID (from clinicaltrials.gov): NCT05773274
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: June 05, 2023

Chair: (Canada) Dr. Simron Singh, Odette Cancer Centre, (416) 480-4928, (USA) Dr. Aman Chauhan, Cancer Trials Support Unit


Open to Accrual
NE2 (AG0219NET)

STOPNET - A Randomized Study of Cessation of Somatostatin Analogues after Peptide Receptor Radionuclide Therapy in Mid, Hind-Gut and Pancreatic Neuroendocrine Tumours

A study of where SSAs are needed after PRRT therapy for patients with neuroendocrine tumours (STOPNET)


Complexity Level: 3

Eligibility: MAIN INCLUSION CRITERIA: Adults over 18 years of age with well or moderately differentiated mid or hindgut neuroendocrine tumour, or pancreatic neuroendocrine tumour; Must have measurable disease; Patients who been receiving SSA for at least 3 months prior to study entry; Patients whose ancer has gotten worse after SSA treatment to warrant therapy with PRRT; PRRT is deemed the most appropriate next treatment step (i.e., patient is inoperable); ECOG PS 0-2 MAIN EXCLUSION CRITERIA: Gastric and lung NETs are excluded; Prior PRRT (patients being considered for re-treatment with PRRT are not eligible); Pregnancy

Objectives: GENERAL AIM: To estimate the outcomes of patients with grade 1 and 2 pancreatic, mid and hind-gut neuroendocrine tumours who have progressed on SSA therapy and receive subsequent PRRT with or without concurrent SSA. CO-PRIMARY OBJECTIVES: - To estimate the 20-month progression free survival rate after PRRT in patients who cease and who continue SSA. - To assess the barriers which would impede the feasibility of a subsequent phase 3 trial: 1) Patient acceptance of ceasing and staying off SSA for the 20-month duration of the study follow up. 2) Ability to complete recruitment over the 24-month recruitment period. SECONDARY OBJECTIVES: - Measure QoL using EORTC QLQ-C30 and EORTC QLQ-GINET21 - Cost-effectiveness of SSA therapy cessation - Psycho-oncological impacts of SSA therapy cessation using the self-reported measures for Fear of Cancer Progression, Decisional Conflict and Decision Regret - Time to commencement of subsequent therapy - OS - Rates of SSA being recommended over time

NCT Registration ID (from clinicaltrials.gov): NCT06345079
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Open to Accrual
Activation Date: July 22, 2024

Chair: (Canada) Dr. Rachel Goodwin, Ottawa Hospital Research Institute, (613) 737-8899 Ext. 70185, (Canada) Dr. Jonathan Loree, Canadian Cancer Trials Group, Queen's University, (613) 533-6430 Ext. 76816


Open to Accrual
PAC3 (ALLIANCE A021806)

Perioperative versus Adjuvant Chemotherapy for Resectable Pancreatic Cancer

The purpose of this study is to compare the usual treatment approach (surgery followed by chemotherapy) to using chemotherapy followed by surgery and then more chemotherapy. The addition of chemotherapy before surgery to the usual treatment approach could extend the life of patients, but it could also cause side effects. This study will help doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the doctors will be looking to see if the study approach increases the life of patients compared to the usual approach. This chemotherapy drug regimen, FOLFIRINOX, is already commonly used in pancreatic cancer. However, most of the time it is not used until after surgery.


Complexity Level: 2

Eligibility: Histologic or cytologic proof of pancreatic adenocarcinoma or adenosquamous carcinoma, TNM Stage: Tx-4, N0-1, M0 Local radiographic reading consistent with resectable disease Confirmation of resectable disease by real-time central imaging review by the Alliance Imaging Core Lab at IROC Ohio Determined to be appropriate candidate for curative-intent pancreatectomy No prior radiation therapy, chemotherapy, targeted therapy, investigational therapy or surgery for pancreatic cancer Not pregnant and not nursing Age > or = to 18 years ECOG Performance Status 0-1 Total Neuropathy Score < 2 No known Gilbert's Syndrome or known homozygosity for UGATA1A1*28 polymorphism No comorbid conditions that would prohibit curative-intent pancreatectomy Chronic concomitant treatment with strong inhibitors and/or inducers of CYP3A4 is not allowed Measurable disease and/or non-measurable disease

Objectives: The primary objective of this study is to evaluate and compare overall survival (OS) in patients with resectable pancreatic adenocarcinoma (PDAC) treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX.

NCT Registration ID (from clinicaltrials.gov): NCT04340141
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Open to Accrual
Activation Date: May 03, 2021

Chair: (Canada) Dr. Daniel John Renouf, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 672357


Open to Accrual
PAC4 (ECOG-ACRIN EA2185)

Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs


Complexity Level: 3

Eligibility: Criteria: - Patients must be >/= 50 years and
Objectives: To compare the rates of unfavorable clinical outcomes in the two arms. For clarity, favorable outcomes comprise: (1) High grade dysplasia (HGD) and/or resectable, early stage, pancreatic cancer (T1a, N0) at surgery; (2) benign disease and no surgery. However, the primary comparison between arms will be in terms of unfavorable outcomes.

NCT Registration ID (from clinicaltrials.gov): NCT04239573
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: On Hold
Activation Date: May 17, 2022

Chair: (Canada) Dr. Paul Karanicolas, Odette Cancer Centre, (416) 480-4774


On Hold
CO21

A Phase III Study of the Impact of a Physical Activity Program on Disease-Free Survival in Patients with High Risk Stage II or Stage III Colon Cancer: A Randomized Controlled Trial (CHALLENGE).


Complexity Level: 3

Eligibility: Medically fit colon cancer patients (high risk stage II and stage III) who have completed adjuvant chemotherapy within the past 60-180 days. Current physical activity levels must not meet the recommended guidelines (>=150 minutes of moderate-to-vigorous or >=75 minutes of vigorous exercise/week). Following registration, and prior to randomization, patients must successfully complete at least two stages of a submaximal exercise test to ensure they are able to safely exercise at a moderate to vigorous intensity.

Objectives: Primary Objective: Disease free survival (DFS) Secondary objectives: 1. To compare the two intervention arms with respect to: - Quality of Life (QOL) - Objective markers of physical fitness - Physical activity behaviour - Overall survival (OS) - Serum levels of insulin, IGF-1, IGF-2 and IGFBP3 - Cytokine levels - Economic evaluations including cost effective and cost-utility analyses - Predictors of physical activity adherence 2. To compare the following evaluations in all randomized patients to assess for potential associations - Molecular markers with DFS, OS, level of physical activity and level of fatigue - Age, gender, country, incremental increase in physical activity and change in aerobic fitness with DFS, OS, level of fatigue and QOL 3. To establish a comprehensive specimen bank linked to a clinical database for the further study of molecular markers in colon cancer

NCT Registration ID (from clinicaltrials.gov): NCT00819208
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Closed to Accrual
Activation Date: December 03, 2008 Closing Date: January 24, 2024

Chair: (Canada) Dr. Kerry Courneya, University of Alberta, (780) 492-1031, (Australia) Dr. Janette Vardy, Sydney Cancer Centre, (29) 767-6345, (Canada) Dr. Chris Booth, Cancer Centre of Southeastern Ontario at Kingston, (613) 549-6666 Ext. 4505


Closed to Accrual
CO27 (IROCAS)

A Phase III, Randomised, International Trial Comparing mFOLFIRINOX Triplet Chemotherapy to mFOLFOX for high Risk Stage III Colon Cancer in Adjuvant Setting


Complexity Level: 2

Eligibility: Inclusion: Adults with pathologically confirmed high-risk stage III colon adenocarcinoma, who have undergone curative R0 surgical resection within 42 days before randomization. No prior abdominal/pelvic radiotherapy and no prior chemotherapy; adequate hematologic function; adequate liver function (bilirubin > 1.5 xUNL), Creatinine clearance > 50 mL/min; patient information and signed informed consent. Exclusions: Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start; metastatic disease; IBS; known hypersensitivity to any of study drugs; clinically relevant CAD or history of MI in last year or uncontrolled arrhythmia; previous malignancy; known DPD deficiency or UGTA1A1 homozygous 7/7.

Objectives: Primary Objective: 3 year Disease Free Survival (DFS) Secondary Objectives: 2 year DFS, Overall Survival, safety of study treatment

NCT Registration ID (from clinicaltrials.gov): NCT02967289
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: May 02, 2017 Closing Date: June 14, 2023

Chair: (Canada) Dr. Sharlene Gill, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2734


Closed to Accrual
CO29 (AGITG CTDNA-08)

Circulating Tumor DNA Analysis Informing Adjuvant Chemotherapy in Stage III Colon Cancer: A Multicentre Phase II/III Randomised Controlled Study (DYNAMIC III)


Complexity Level: 2

Eligibility: - Patients aged >=18 years of age - Subjects with curatively resected stage III (Any T, N1 or N2, M0) colorectal cancer - Patients with rectal cancer will be eligible unless they have had pre-operative combined chemotherapy and radiotherapy, or are scheduled for post-operative combined chemotherapy and radiotherapy. All rectal cancer patients must have had TME type surgery with negative (R0) resection margins. - A representative tumour sample is available for molecular testing up to 6 weeks after surgery (refer to section 9.1.1 for a more specific timeframe) - Fit for at least single agent fluoropyrimidine adjuvant chemotherapy - ECOG performance status 0-2 - No metastatic disease

Objectives: Primary objective: To evaluate the impact of a de-escalation/escalation treatment strategy using ctDNA-informed management. The ctDNA positive and negative cohorts will be evaluated separately: (a) For ctDNA negative patients: de-escalation treatment strategy is non-inferior to standard of care (b) For the ctDNA positive patients: escalation treatment strategy is superior to standard of care. Secondary objectives: To demonstrate (1) ctDNA-informed adjuvant therapy approach will not compromise RFS in patients with NEGATIVE post-op ctDNA; (2) an acceptable rate of de-escalation in the ctDNA-informed negative cohort; (3) 3-year RFS rates between ctDNA-informed therapy and standard of care in patients with POSITIVE post-op ctDNA; (4) OS between ctDNA-informed therapy and standard of care in patients with POS & NEG post-op ctDNA; (5) end of treatment ctDNA results with RFS and OS; (6) feasibility of adjuvant chemo strategy based on post-op ctDNA results; (7) Heath economic impact

Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: February 09, 2021 Closing Date: March 31, 2023

Chair: (Canada) Dr. Jonathan Loree, Canadian Cancer Trials Group, Queen's University, (613) 533-6430 Ext. 76816


Closed to Accrual
CRC3 (ECOG E5202)

A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients With Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers


Complexity Level: 2

Eligibility: Patients must have histologically confirmed adenocarcinoma of the colon that meets the criteria below: Stage II carcinoma (T3,4 N0 M0): The tumor invades through the muscularis propria into the subserosa or into non-peritonealized pericolic or perirectal tissues (T3) or directly invades other organs or structures and/or perforates visceral peritoneum (T4). The distal extent of the tumor must be > 12 cm from the anal verge on endoscopy. If the patient is not a candidate for endoscopy, then the distal extent of the tumor must be > 12 cm from the anal verge as determined by surgical examination. Patients must have paraffin-embedded tumor specimen available for evaluation of microsatellite instability and loss of heterozygosity at 18q, to determine high risk versus low risk. Tumor samples and normal mucosa will be shipped as specified in Section 10.2. High-risk patients will be randomized to treatment Arms A or B. Low-risk patients will be registered to Arm C for observation.

Objectives: Primary: To demonstrate an improvement in 3-year disease-free survival for high-risk stage II colon cancer patients randomly assigned to 5-FU, leucovorin, oxaliplatin versus 5-FU, leucovorin, oxaliplatin and bevacizumab. Secondary: To compare overall survival between the regimens.To further define the toxicity profiles of the regimens. To prospectively determine the impact of tumor biological characteristics on survival.

NCT Registration ID (from clinicaltrials.gov): NCT00217737
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: April 27, 2006 Closing Date: February 11, 2011

Chair: (Canada) Dr. Sheryl Koski, Cross Cancer Institute, (780) 432-8513


Closed to Accrual
CRC6 (CALGB C80702)

A Phase III Trial of 6 versus 12 Treatments of Adjuvant Folfox Plus Celecoxib or Placebo For Patients With Resected Stage III Colon Cancer


Complexity Level: 2

Eligibility: Histologically documented adenocarcinoma of the colon. The gross inferior (caudad) margin of the primary tumor must be at least 12 centimeters from the anal verge (i.e., patients with rectal cancer are not eligible).

Objectives: To compare disease-free survival of patients with stage III colon cancer randomized to standard chemotherapy only (FOLFOX) or standard chemotherapy (FOLFOX) with 3 years of celecoxib 400 mg daily.

NCT Registration ID (from clinicaltrials.gov): NCT01150045
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: March 28, 2011 Closing Date: November 20, 2015

Chair: (Canada) Dr. Felix Couture, CHUQ - Hotel-Dieu de Quebec, (418) 691-5225


Closed to Accrual
CRC7 (ALLIANCE N1048)

A Phase II/III Trial of Neoadjuvant FOLFOX, with Selective Use of Combined Modality Chemoradiation versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mesorectal Excision (PROSPECT)


Complexity Level: 2

Eligibility: Histologically confirmed clinical stage T2N1, T3N0, T3N1 (stage IIA, IIIA, or IIIB) adenocarcinoma of the rectum where standard treatment recommendation would be combined modality neoadjuvant chemoradiation followed by curative intent surgical resection

Objectives: Primary Outcomes: Pelvic R0 resection rate (phase II) DFS (Phase III) Time to local recurrence (TLR)

NCT Registration ID (from clinicaltrials.gov): NCT01515787
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: October 17, 2012 Closing Date: December 28, 2018

Chair: (Canada) Dr. Rebecca Ann Auer, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 72791


Closed to Accrual
CRC8 (ECOG-ACRIN EA2165)

A Randomized Phase III Study of Nivolumab after Combined Modality Therapy (CMT) in High-Risk Anal Cancer


Complexity Level: 2

Eligibility: Registration step 1: Patients with histologically proven stage II (T3N0 only), IIIA, or IIIB invasive anal squamous cell carcinoma. For patients registering to Arm T, they must not have received prior chemoradiotherapy for anal cancer. Registration to step 2: Patients will be registered no sooner than 4 weeks following completion of standard chemoradiation for anal cancer (no less than 54 Gy). Patients must have histologically proven state II (T3N0 only), IIIA, or IIIB invasive anal squamous cell carcinoma.

Objectives: Primary objective: To evaluate whether therapy with nivolumab following combined modality therapy (CMT) improves Disease-Free Survival (DFS) compared with observation in patients with high risk anal carcinoma. Secondary objectives: To compare nivolumab following combined modality therapy (CMT) with observation in patients with high risk anal carcinoma with ragard to objective response rate (complete CR and partial PR), stable disease and progression; severe toxicity interval; colostomy-free survival; overall survival; toxicity.

NCT Registration ID (from clinicaltrials.gov): NCT03233711
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: August 16, 2018 Closing Date: August 24, 2021

Chair: (Canada) Dr. Michael Vickers, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 70185


Closed to Accrual
CRC9 (NRG-GI005)

Phase II/III Study of Circulating tumOr DNA as a Predictive BiomarRker in Adjuvant Chemotherapy in Patients with Stage IIA Colon Cancer (COBRA)


Complexity Level: 3

Eligibility: Patients must 1) have histologically/pathologically confirmed stage 2A adenocarcinoma of colon with at least 12 LNs examined at resection 2) be appropriate for active surveillance 3) distal extent of tumor must be 12cm from the anal verge 4) complete gross tumor resection (curative resection) within 14-60 d of randomization 5) adequate tumor for testing 6) adequate hematologic-hepatic-renal function within 28 d before randomization 7) ECOG 0 or 1 8) only adenocarcinoma colon cancer histology 9) no metastatic disease 10) no tumor-related bowel perforation, history of prior invasive colon malignancy or organ transplantation 11) no prior systemic chemo, targeted therapy, IO, or RT for CRC 12) no other invasive malignancy & no antineoplastic therapy within 5 yrs before randomization 13) no uncontrolled cardiac disease 14) no sensory or motor neuropathy gr 2, active uncontrolled seizure disorder, active or chronic infection requiring systemic therapy, known homozygous DPD deficiency

Objectives: PRIMARY OBJECTIVE (PH 2) - To compare the rate of ctDNA clearance in "ctDNA detected" patients treated with or without adjuvant chemotherapy following resection of stage IIA colon cancer PRIMARY OBJECTIVE (PH 3) - To compare RFS in "ctDNA detected" patients treated with or without adjuvant chemotherapy following resection of stage IIA colon cancer SECONDARY OBJECTIVES - in patients with stage IIA colon cancer: - To describe the prevalence of detectable ctDNA following surgical resection - To estimate time-to-event outcomes (OS, RFS, TTR) by ctDNA marker status & treatment - To estimate the rate of compliance with adjuvant chemotherapy &/or active surveillance EXPLORATORY OBJECTIVES: - To describe the association of quantitative ctDNA levels with time to event outcomes (RFS, OS, & TTR) - To characterize genomic profiles associated with recurrence using a ctDNA assay - To model the cost effectiveness of the use of ctDNA vs SOC in this setting

NCT Registration ID (from clinicaltrials.gov): NCT04068103
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: April 21, 2020 Closing Date: February 15, 2024

Chair: (Canada) Dr. Howard Lim, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 672699


Closed to Accrual
GA1 (TROG 0808)

A Randomized Phase II/III Trial of Preoperative Chemoradiotherapy versus Preoperative Chemotherapy For Resectable Gastric Cancer (TOPGEAR)


Complexity Level: 2

Eligibility: Patients with resectable adenocarcinoma of stomach or gastroesophageal junction, Stage IB (T1N1) - IIIC (T3,4 and/or N+ve).

Objectives: Primary: Overall Survival Secondary: DSF, toxicity, pCR rate, Surgical R0 Resection rate, , QoL; Economics; A biologic correlate

NCT Registration ID (from clinicaltrials.gov): NCT01924819
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: July 31, 2013 Closing Date: July 01, 2021

Chair: (Canada) Dr. Rebecca Wong, University Health Network, (416) 946-2126


Closed to Accrual
GA3 (AGITG-AG0315OG)

A Randomised Phase III Double-Blind Placebo-Controlled Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer (AGOC)


Complexity Level: 2

Eligibility: Adults with histologically or cytologically confirmed advanced gastro-oesophageal Cancer (AGOC), with measurable metastatic or locally advanced disease, who have failed or were intolerant of 2 lines of prior anti-cancer therapy which have included a platinum & fluoropyrimidine analogue.

Objectives: Primary Objective: OS in overall study population and in the Asian sub-population Secondary Objectives: PFS, Objective tumour response rate (PR or CR); Quality of life (QoL); Safety (rates of adverse events)

NCT Registration ID (from clinicaltrials.gov): NCT02773524
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: January 09, 2017 Closing Date: February 03, 2021

Chair: (USA) Dr. Thierry Alcindor, Dana-Farber Cancer Institute


Closed to Accrual
NEC3 (ALLIANCE A021202)

Prospective Randomized Phase II Trial of Pazopanib (NSC# 737754, IND 75648) Versus Placebo in Patients with Progressive Carcinoid Tumors


Complexity Level: 2

Eligibility: Patients with low or intermediate grade neuroendocrine carcinoma arising from the foregut, midgut, hindgut or other non-pancreatic site which is locally unresectable or metastatic. Must have measurable disease with radiological evidence of PD (may be either measure or non-measure PD). No prior treatment with an inhibitor of VEGF or VEGFR.

Objectives: Primary Objectives: PFS Secondary Objectives: Objective tumour response rate (PR or CR); Overall survival (OS); Duration of Response (DR); Time to treatment failure (TTF) and Time to second progression for patients who crossover from placebo to active therapy.

NCT Registration ID (from clinicaltrials.gov): NCT01841736
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: February 28, 2014 Closing Date: October 07, 2016

Chair: (Canada) Dr. Tim Asmis, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 79556


Closed to Accrual
PA7 (PA7)

A Randomized Phase II Trial of Gemcitabine and Nab-Paclitaxel vs Gemcitabine, Nab-Paclitaxel, Durvalumab and Tremelimumab as 1st Line Therapy in Metastatic Pancreatic Adenocarcinoma


Complexity Level: 2

Eligibility: Inclusion Criteria: Metastatic pancreatic ductal adenocarcinoma No prior treatment for metastatic disease May have received prior adjuvant Gemcitabine if longer then 6 months before recurrence Archival tissue available for correlative analysis ECOG PS 0,1 Exclusion Criteria: Medical contraindications to Gemcitabine or Nab-Paclitaxel Medical contraindications to MEDI 4736 (e.g. autoimmune disease)

Objectives: Primary: - overall survival (OS) Secondary: -Progression Free Survival (PFS) - Toxicity and Safety - Objective Response Rate (ORR) Tertiary Endpoints: - Quality of Life (QoL) - Correlative Studies (PD-L1, hENT/SPARC,gene expression, ciruclating tumour DNA)

NCT Registration ID (from clinicaltrials.gov): NCT02879318
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Permanently Closed
Activation Date: August 22, 2016 Closing Date: July 26, 2018

Permanently Closed