Head & Neck Disease Site

The Canadian Cancer Trials Group Central Operations and Statistics Centre will be closed on Friday, April 19, 2019 for Good Friday. Regular business hours will resume on Monday, April 22 at 8:30 am EDT.
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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
Comparing Radiation Plus Antibody Therapy to Radiation Plus Immune Therapy in People With Advanced Head and Neck Cancer Who Cannot Take 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: Planned

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


Planned
HN10A Phase II Single Arm Trial of Elective Volume Adjusted De-Escalation Radiotherapy (EVADER) in Patients with Low-risk HPV-related Oropharyngeal Squamous Cell Carcinoma
This is a phase II, single arm, open-label, multi-centre cooperative group trial of elective volume adjusted de-escalation radiotherapy in patients with low-risk human papillomavirus (HPV)-related oropharyngeal squamous cell carcinoma (OPSCC).

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
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
HN9Randomized 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)
Immunotherapy is a new type of treatment strategy for many different cancer types. Two types of new immunotherapy drugs are called durvalumab and tremelimumab. Laboratory tests show that these drugs work by allowing the immune system to detect cancer and reactivate the immune response. This may help to slow down the growth of cancer or may cause cancer cells to die. The HN.9 study tests how well four different treatment strategies (three of which include immunotherapy) work for patients with advanced, HPV-positive, head and neck cancer that has not spread to other areas. The four 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 durvalumab (given at the same time); 4) RT and a standard chemotherapy drug called cisplatin (given at the same time). Note: the fourth option does not include immunotherapy.

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 N2b (smoking >10 pack-years) - T3 N0-N2b (smoking >10 pack-years) - T1-3 N2c (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
HN1A 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
HN2A 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
HN3A Comparison of Acute Oral Mucositis Between Morning and Afternoon Radiotherapy in Patients Receiving Radiation Treatment for Cancer of the Head and Neck
The purpose of the study is to find out whether giving the radiotherapy treatment in the morning (between 8 and 10 AM) or giving the same treatment in the late afternoon (between 4 and 6 PM) causes the same degree of mucositis. To do this, half of the patients in the study will get the treatments in the morning and the other half will get the treatments in the afternoon.

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
HN4A Phase II Study of Cisplatin and Gemcitabine in Patients with Locally Advanced/Recurrent or Metastatic Malignant Salivary Gland Tumours
The purpose of this study is to find out what effects a new drug combination, cisplatin or carboplatin in combination with gemcitabine, has on you and your salivary gland tumour. This research is being done because currently there is no treatment that can cure this type of cancer and these drugs seem promising when tested in a small number of people with 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
HN5A 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
This is a study assessing the effects of OSI-774 in people with cancer of the head and neck. The purpose of this study is to evaluate the side effects, drug levels and tumour effects of OSI-774 and to determine the best dose of OSI-774 to use for future studies. This is done by starting at a dose lower than the one found effective in previous studies. Patients are given OSI-774 and are watched very closely to see what side effects they have and to make sure the side effects are not severe. If the side effects are not severe, then more patients are asked to join the study at a higher dose of OSI-774. If the side effects are severe, then more patients are asked to join the study at a lower dose of OSI-774. Patients joining the study later on will get a higher dose of OSI-774 (TarcevaTM) than patients who join earlier. This is a part of the study plan to see which dose is better tolerated in patients.

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
HN6A 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.
The purpose of this study is to compare the effects of accelerated radiotherapy with the drug panitumumab compared to standard radiotherapy with cisplatin chemotherapy. This research is being done because panitumumab and accelerated radiotherapy are promising treatments for head and neck cancer. We do not know if this may be better, the same, or worse at controlling the cancer than standard treatment. Panitumumab is a type of antibody therapy which acts against a protein on tumour cells called the epidermal growth factor receptor. Panitumumab belongs to a class of drugs call "EGFR inhibitors". Other EGFR inhibitors similar to panitumumab have been shown to slow the growth of head and neck cancer when combined with radiotherapy. Panitumumab has been shown to slow the growth of advanced colon cancer.

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
I105NCIC 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