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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

The purpose of this study is to find out whether radiotherapy to some of the lymph node areas can be safely left out of the treatment plan to decrease side effects without increasing the risk of the tumour coming back. The standard or usual treatment for this disease includes radiotherapy or radiotherapy combined with chemotherapy or antibody therapy. These treatments are highly effective at curing most patients with HPV-related cancer of the oropharynx, but short and long-term side effects from treatment can be significant.


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: Open to Accrual
Activation Date: February 20, 2019

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


Open 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)

The purpose of this study is to test how well three different treatment strategies (two of which include immunotherapy) work for patients with HPV-positive, head and neck cancer that has not spread to other areas. The three treatment strategies are 1) radiation therapy (RT) and durvalumab (given at the same time) followed by durvalumab alone; 2) RT and durvalumab (given at the same time) followed by durvalumab and tremelimumab; 3) RT and a standard chemotherapy drug called cisplatin (given at the same time).


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: Open to Accrual
Activation Date: January 31, 2018

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


Open 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

This randomized phase II/III trial studies how well radiation therapy works with durvalumab or cetuximab in treating patients with head and neck cancer that has spread to a local and/or regional area of the body who cannot take cisplatin. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as durvalumab or cetuximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not known if radiation therapy with durvalumab will work better than the usual therapy of radiation therapy with cetuximab in treating patients with head and neck cancer.


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: Open to Accrual
Activation Date: May 10, 2019

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


Open 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

Chair: (Canada) Dr. Samy El-Sayed, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 70197


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

Chair: (Canada) Dr. Georg A. Bjarnason, Odette Cancer Centre, (416) 480-6100 Ext. 5847


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

Chair: (Canada) Dr. Lillian Siu, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2911


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

Chair: (Canada) Dr. Denis Soulieres, CHUM-Centre Hospitalier de l'Universite de Montreal, (514) 890-8000 Ext. 25381


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

Chair: (Canada) Dr. John Waldron, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-6522, (Canada) Dr. Lillian Siu, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2911


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

Chair: (Canada) Dr. Lillian Siu, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2911


Permanently Closed