Head & Neck Disease Site

Head & Neck

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HN12

A Phase II Study of PembROlizumab with or without Microbial EcOsystem ThErapeutic 4 (MET4) in Advanced Head and Neck Squamous Cell Carcinoma (PROMOTE-HN)


Complexity Level: 2

Eligibility: MAIN INCLUSION CRITERIA: histologically or cytologically confirmed R/M HNSCC considered incurable by local therapies. No prior systemic therapy administered in the recurrent or metastatic setting. At least 18 years of age. Measureable disease per RECIST 1.1. ECOG performance status of 0 or 1. Adequate organ function. PD-L1 positive tumour. Able to access pembrolizumab. Able to swallow oral medication. MAIN EXCLUSION CRITERIA: Disease suitable for local/curative therapy. PD within 6 months of completion of curative treatment. Toxicity greater than gr. 2 related to prior therapy. Life expectancy less than 3 months. Diagnosis of immunodeficiency. History of other malignancies. Active CNS mets. Autoimmune disease. Allogeneic tissue/solid organ transplant. Active infection. Prior therapy with anti-PD-1, PD_L1 or PD-L2 agent. Active Hepatitis B. Live vaccine within 30 days. Pregnancy or breastfeeding.

Objectives: PRIMARY: To estimate the Objective Response Rate (ORR) per RECIST 1.1 in first line recurrent and/or metastatic (R/M) HNSCC subjects, treated with pembrolizumab in combination with MET-4 or pembrolizumab with placebo. SECONDARY: To estimate and describe the following in each of the two treatment arms: Microbial community composition , Progression free survival (PFS) as per RECIST 1.1 , Overall survival (OS) , Duration of response (DOR) , Safety and tolerability (CTCAE version 5.0) TERTIARY: To identify tissue, stool, oral swab and blood-based molecular and immune biomarkers of clinical response or resistance, toxicity, and/or the mechanism of action of pembrolizumab in combination with MET-4. To compare the two treatment arms with respect to changes from baseline in quality of life. To estimate the two treatment arms with respect to ORR as defined by iRECIST.

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

Chair: (Canada) Dr. Anna Spreafico, University Health Network, (416) 946-4501 Ext. 4012


Planned
HN13

Optimizing Head and Neck Tumour And Symptom Control in Patients Unable to Tolerate Curative Intent RT: A Phase III Trial Comparing Stereotactic Body Radiation Therapy (SBRT) to Standard Palliative Radiation Treatment (ON-TASC Study)


Complexity Level: 1

NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: CCTG Led Trial
Status: Planned

Chair: (Canada) Dr. Ian D.T. Poon, Odette Cancer Centre, (416) 480-4974


Planned
HN11 (HN.11)

SPECT-CT Guided ELEctive Contralateral Neck Treatment (Select) for Patients with Lateralized Oropharyngeal Cancer. A Phase III Randomized Controlled Trial

This study is being done to answer the following question: Is both the chance of the cancer spreading or returning the same if radiotherapy to the neck is guided by using a special imaging study called lymph node mapping (lymphatic mapping) Single Photon Emission Computed Tomography (SPECT-CT) compared to the usual treatment when radiotherapy is given to both sides of the neck? We are doing this study because we want to find out if this approach is better or worse than the usual approach in controlling the cancer and has fewer side effects and better quality of life.


Complexity Level: 1

Eligibility: Patients with pathologically proven diagnosis of lateralized OPC (tonsil, tongue base, soft palate, or pharyngeal wall) not involving or crossing midline; HPV positive or negative (by p16 immunohistochemistry); Clinical stage T1-3 M0 (UICC/AJCC TNM 8th Edition); Nodal disease may include no nodes or single or multiple ipsilateral lymph nodes (largest should be less than 6 cm in maximum diameter); Planned definitive RT or CRT with bilateral neck RT (patients planned for unilateral neck RT are excluded); Must be willing to complete quality of life questionnaires.

Objectives: Primary: To determine if a lymphatic mapping-guided approach (experimental arm) for management of the contralateral neck has a non-inferior disease-free survival (DFS) compared to bilateral neck RT (control arm) in patients with lateralized OPC not involving or crossing the midline and without clinical contralateral nodal disease. Secondary: To compare between arms the following: swallowing-related and xerostomia quality of life (QOL); isolated contralateral neck failure, overall survival, loco-regional failure, distant metastasis; RT-related toxicities, patient reported toxicities, gastrostomy tube usage, economic analyses. Exploratory: swallowing function using videofluoroscopy (sub study); Head and Neck QOL; patterns of lymphatic drainage; predicting contralateral lymphatic drainage on SPECT-CT; to correlate baseline tumor somatic mutations with recurrence; to correlate circulating cell free DNA (cfDNA) with clinical recurrence after treatment.

NCT Registration ID (from clinicaltrials.gov): NCT05451004
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: September 29, 2022

Chair: (Canada) Dr. John de Almeida, University Health Network, (416) 946-4501, (Canada) Dr. Ali Hosni Abdalaty, University Health Network, (416) 946-4501 Ext. 2126


Open to Accrual
HN10

A Phase II Single Arm Trial of Elective Volume Adjusted De-Escalation Radiotherapy (EVADER) in Patients with Low-risk HPV-related Oropharyngeal Squamous Cell Carcinoma


Complexity Level: 2

Eligibility: Patients with pathologically proven diagnosis of HPV-related OPSCC. Clinical stage T1-3 N0-1 M0. Patients must be eligible for definitive RT or CRT, >= 18 years of age, ECOG 0-2. Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French. Patients must be accessible for treatment and follow up.

Objectives: Primary Objective: To evaluate the efficacy of primary definitive radiotherapy (RT) or chemoradiotherapy (CRT) utilizing volume reduced elective nodal irradiation (ENI) as measured by 2-year progression-free survival (PFS) in patients with low-risk HPV-related OPSCC. Secondary Objectives: To evaluate other metrics for efficacy and safety, early and late toxicities of treatment, objective swallowing and salivary functions, quality of life (QOL), utilization of healthcare resources, work productivity, and prognostic biomarkers. Tertiary Objectives: To assemble an imaging and biospecimen bank for future research that could improve risk stratification and patient selection for volume-reduced ENI.

NCT Registration ID (from clinicaltrials.gov): NCT03822897
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: CCTG Led Trial
Status: Closed to Accrual
Activation Date: February 20, 2019 Closing Date: December 02, 2021

Chair: (Canada) Dr. Scott Bratman, University Health Network, (416) 946-4501, (Canada) Dr. Kathy Han, University Health Network, (416) 946-4501 Ext. 2919


Closed to Accrual
HN9

Randomized Phase II Study of Cisplatin plus Radiotherapy versus Durvalumab plus Radiotherapy followed by Adjuvant Durvalumab versus Durvalumab plus Radiotherapy followed by Adjuvant Tremelimumab and Durvalumab in Intermediate Risk HPV-Positive Locoregionally Advanced Oropharyngeal Squamous Cell Cancer (LA-OSCC)


Complexity Level: 2

Eligibility: 1) Histologically and/or cytologically confirmed (primary lesion or regional lymph nodes) squamous cell carcinoma of the oropharynx (OSCC) which is locoregionally advanced, intermediate risk and non-metastatic (M0) as defined by the following: - T1-2 N1 (smoking >10 pack-years) - T3 N0-N1 (smoking >10 pack-years) - T1-3 N2 (any smoking history) 2) Human papillomavirus (HPV)-related as determined by positive p16 immunohistochemical staining on any tumoural specimens. 3) Performance status of 0 or 1. 4) > 18 years of age. 5) Patient must consent to release of tumour tissue, blood, saliva and throat swab samples for correlative studies. 6) Adequate normal organ and marrow function.

Objectives: Primary: To estimate the efficacy (in terms of event-free survival) of 3 treatment Arms: (A) radiotherapy (RT) and cisplatin; (B) RT and durvalumab followed by adjuvant durvalumab; and (C) RT and durvalumab followed by adjuvant durvalumab and tremelimumab in patients with intermediate risk, HPV-positive, locally advanced oropharyngeal squamous cell carcinoma of the head and neck (LA-OSCC). Secondary: 1) To assess differences between arms in change in FACT-HN score from baseline to 36 months post-RT; 2) To estimate and describe the following in each of the 3 treatment arms: Locoregional control; Distant metastasis-free survival (DMFS); OS; Toxicity; Incidence of second cancer; Dysphagia; PRO-CTCAE Radiation related late toxicity; Cost effectiveness; Cost utility; and lost productivity. Tertiary: 1) Correlative Studies; 2) Event-free survival as defined by iRECIST.

NCT Registration ID (from clinicaltrials.gov): NCT03410615
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Closed to Accrual
Activation Date: January 31, 2018 Closing Date: November 16, 2022

Chair: (Canada) Dr. Anna Spreafico, University Health Network, (416) 946-4501 Ext. 4012, (Canada) Dr. Khalil Sultanem, The Jewish General Hospital, (514) 340-8288


Closed to Accrual
HNC2 (NRG HN004)

Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) vs Radiotherapy with Concurrent Cetuximab in Patients with Stage III-IVB Head and Neck Cancer with a Contraindication to Cisplatin


Complexity Level: 2

Eligibility: Eligibility Criteria include: p16 and PD-L1 status by submission of tissue samples, pathologically confirmed, previously untreated, unresected squamous cell carcinoma of larynx, hypopharynx, oropharynx, oral cavity or unknown head and neck primary within 60 days of registration (locoregionally advanced HNSCC), contraindication to cisplatin, adequate hematological hepatic and renal function, negative pregnancy test (if applicable)

Objectives: Phase II: Primary objective is PFS. Phase III: Primary objective is OS. Secondary objectives include: Toxicity profile, effects of anti-PD-L1 therapy, OS, response, loco-regional failure, distant metastasis, and competing mortality, Quality of Life, swallowing related QoL and performance, gastronomy tube retention Exploratory objectives include: immune response, short term QoL, short term swallowing related QoL, patient reported fatigue, and health utilities

NCT Registration ID (from clinicaltrials.gov): NCT03258554
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: May 10, 2019 Closing Date: September 01, 2022

Chair: (Canada) Dr. Eric W. Winquist, London Regional Cancer Program, (519) 685-8261


Closed to Accrual
HN1

A Phase III Study Evaluating the Role of Elective Neck Dissection in the Management of Oral Carcinoma


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: October 17, 1995 Closing Date: May 08, 1998

Permanently Closed
HN2

A Double-Blind Phase III Randomized Study of Bacitracin, Clotrimazole, Gentamicin (Bcog) Lozenges versus Placebo Lozenges for Radiation-Associated Mucositis in Head and Neck Cancer


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: September 22, 1997 Closing Date: July 30, 1999

Permanently Closed
HN3

A Comparison of Acute Oral Mucositis Between Morning and Afternoon Radiotherapy in Patients Receiving Radiation Treatment for Cancer of the Head and Neck


Eligibility: Patients with squamous cell carcinoma of the oral cavity, pharynx (oro, hypo and naso), or larynx, who are to receive radiation treatment to a significant part of the oral and/or pharyngeal mucosa where the reaction will be visible.

Objectives: To compare the toxicity of radiotherapy to the oral mucosa delivered in the morning and the late afternoon; to compare grades and duration of mucositis, incidence of clinically significant mucositis using a validated mucositis scoring system, treatment days lost because of treatment reactions, incidence of late toxicity, changes in body weight, complete response rates, survival and quality of life.

NCT Registration ID (from clinicaltrials.gov): NCT00004234
Participation: Not limited
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 02, 1999 Closing Date: November 15, 2004

Permanently Closed
HN4

A Phase II Study of Cisplatin and Gemcitabine in Patients with Locally Advanced/Recurrent or Metastatic Malignant Salivary Gland Tumours


Eligibility: Patients will have documented evidence of locally advanced recurrent and/or metastatic malignant salivary gland tumours deemed to be incurable by surgery or radiation. Patients may have had up to one prior chemotherapy regimen for locally advanced recurrent/metastatic disease provided that it was non cisplatin/carboplatin or gemcitabine containing and at least 4 weeks have elapsed since chemotherapy discontinuation and study registration. Adjuvant chemotherapy (including cisplatin or carboplatin based regimens) is allowed provided that a minimum of 12 months has elapsed.

Objectives: Primary: To estimate the activity of combination cisplatin (or carboplatin) and gemcitabine among patients with malignant salivary gland tumours which are locally recurrent or metastatic. Secondary: Measurement of complete response Measurement of duration of response Assessment of the toxicity profile of the combination regimen Measurement of overall survival

NCT Registration ID (from clinicaltrials.gov): NCT00079079
Participation: Limited to invited centres only.
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: October 23, 2003 Closing Date: May 05, 2008

Permanently Closed
HN5

A Phase I Study of Adjuvant OSI-774 (Tarceva) in Patients Following Combined Chemo-Radiotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck


Eligibility: Patients with locally advanced squamous cell carcinoma of the head and neck (stages III, IVA or IVB) post treatment with combined chemo-radiotherapy (cisplatin based). Patients must have no evidence of disease or presence of inoperable minimal residual disease at the time of registration.

Objectives: To evaluate the toxicity and determine the recommended dose of OSI-774. To evaluate the effect(s) of OSI-774 on plasma and urinary angiogenic factors (specifically VEGF, VEGFR, VEGFR2, bFGF levels) before, during and after therapy. To correlate angiogenic factor levels with initial blood vessel concentration in the tumour and with the presence or absence of EGFRvIII mutation. To document disease free survival (DFS).

NCT Registration ID (from clinicaltrials.gov): NCT00079053
Participation: Limited to invited centres only.
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 05, 2003 Closing Date: March 31, 2008

Permanently Closed
HN6

A Phase III Study Of Standard Fractionation Radiotherapy With Concurrent High-Dose Cisplatin Versus Accelerated Fractionation Radiotherapy With Panitumumab In Patients With Locally Advanced Stage III And IV Squamous Cell Carcinoma Of The Head And Neck.


Complexity Level: 1

Eligibility: Patients with histologically confirmed squamous cell carcinoma of the head and neck of the oral cavity, oropharynx, larynx or hypopharynx which is locally advanced as defined by TanyN+M0 or T3-4N0M0.

Objectives: The primary objective is progression free survival. The secondary objectives include: overall survival, local progression free survival, regional progression free survival, distant metastasis, acute and late adverse events, quality of life, swallowing related quality of life, functional swallowing outcome (selected centres), significance of tissue and blood biomarkers, and health economics.

NCT Registration ID (from clinicaltrials.gov): NCT00820248
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 18, 2008 Closing Date: November 07, 2011

Permanently Closed
I105

NCIC CTG Phase II Study of 776C85 Plus 5FU in Head and Neck Cancer


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: February 10, 1997 Closing Date: February 22, 1999

Permanently Closed
I157 (PHL002)

A Phase I/II Study of OSI-774 in Combination With Cisplatin in Patients With Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (Princess Margaret Hospital Phase II Consortium - PHL 002)


Eligibility: Recurrent, unresectable and/or metastatic squamous cell cancer of the head and neck; no prior chemotherapy for recurrent/metastatic disease; unidimensionally measurable disease; patients must have completed any prior radiotherapy > 4 weeks before study entry

Objectives: To determine the objective response rate of OSI-774 in combination with cisplatin in patients with recurrent or metastatic squamous cell cancer of the head and neck.

NCT Registration ID (from clinicaltrials.gov): NCT00030576
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: February 10, 2003 Closing Date: September 22, 2004

Permanently Closed