Head & Neck Disease Site

Head & Neck

ID Sort	Study Title	Status Sort
HN11 (CCTG HN.11)	SPECT-CT Guided ELEctive Contralateral Neck Treatment (Select) for Patients with Lateralized Oropharyngeal Cancer. A Phase III Randomized Controlled Trial Read More 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); Head and Neck QOL, isolated contralateral neck failure, overall survival, loco-regional failure, distand metastasis; toxicities, patient reported toxicities, gastrostomy tube usage, economic analyses. Exploratory: swallowing function using videofluoroscopy (sub study); patters 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. Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: CCTG Led Trial Status: Planned 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	Planned
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) Read More Complexity Level: 2 NCI US Affiliation: No Clinical Trials Application (Canada): No 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) Read More 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
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). Read More 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. Read More 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
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 Read More 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
HN1	A Phase III Study Evaluating the Role of Elective Neck Dissection in the Management of Oral Carcinoma Read More 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 Read More 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 Read More 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 Read More 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 Read More 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. Read More 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 Read More 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) Read More 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

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