Head and Neck Cancer Clinical Trial
Official title:
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
Verified date | April 2020 |
Source | Canadian Cancer Trials Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in higher doses over a shorter period of time may kill more tumor cells and have fewer side effects. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving standard radiation therapy together with high-dose cisplatin is more effective than giving higher-dose radiation therapy together with panitumumab in treating patients with locally advanced head and neck cancer. PURPOSE: This randomized phase III trial is comparing two radiation therapy regimens to see how well they work when given together with cisplatin or panitumumab in treating patients with locally advanced stage III or stage IV head and neck cancer.
Status | Completed |
Enrollment | 320 |
Est. completion date | February 17, 2017 |
Est. primary completion date | May 16, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | DISEASE CHARACTERISTICS: - Histologically and/or cytologically confirmed (primary lesion or regional lymph nodes) squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx - Locally advanced disease, defined by any of the following criteria: - Any T, N+, M0 - T3-4, N0, M0 - No current history of unknown primary squamous cell carcinoma of the head and neck, primary nasopharyngeal, paranasal, or salivary gland tumors of the head and neck PATIENT CHARACTERISTICS: - ECOG performance status 0-1 - Absolute granulocyte count = 1.5 x 10^9/L - Platelet count = 100 x 10^9/L - Bilirubin = 1.5 times upper limit of normal (ULN) - AST or ALT = 3 times ULN - Creatinine clearance > 50 mL/min - Magnesium > 0.5 mmol/L - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for = 6 months after completion of study treatment - Must be accessible for treatment and follow-up - Able (sufficiently fluent) and willing to complete the quality of life (QOL) and swallowing QOL questionnaires in either English or French - Must be assessed by a radiation oncologist and medical oncologist and deemed suitable for study participation - No other malignancies within the past 5 years, except adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, or other curatively treated solid tumors - No history of allergic or hypersensitivity reactions to any of the study drugs or their excipients - No prior or concurrent interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) on baseline CT scan - No peripheral neuropathy = grade 2 (CTCAE v3.0) - No hearing loss/tinnitus = grade 3 (CTCAE v3.0) - No thromboembolic event within the past 12 months despite being treated with anticoagulation drugs - Prior thromboembolic event > 12 months allowed provided patient is stable on anticoagulation or on preventative anticoagulation - None of the following allowed: - Myocardial infarction within the past 12 months - Uncontrolled severe congestive heart failure - Unstable angina - Active cardiomyopathy - Unstable ventricular arrhythmia - Uncontrolled hypertension - Uncontrolled psychiatric disorder - Active serious infection - Active peptic ulcer disease - Any other medical condition that might interfere with protocol therapy delivery PRIOR CONCURRENT THERAPY: - No prior surgical treatment except diagnostic biopsy for this disease - No prior induction chemotherapy for this disease - No prior radiation to the head and neck region that would result in overlap of fields for this study - No prior cisplatin or carboplatin chemotherapy - No prior targeted anti-EGFR therapy of any kind - At least 30 days since any prior investigational agent - No concurrent granulocytic growth factors (e.g., filgrastim [G-CSF]) during radiotherapy - No concurrent erythropoietic growth factors, pilocarpine, amifostine, other anticancer therapy (e.g., cytotoxic agents, biological response modifiers, immunotherapy, or hormonal therapy), or other investigational drug therapy - The following radiological investigations must be done within 8 weeks of randomization: - MRI or CT of the head and neck - CT chest |
Country | Name | City | State |
---|---|---|---|
Canada | Cross Cancer Institute | Edmonton | Alberta |
Canada | Juravinski Cancer Centre at Hamilton Health Sciences | Hamilton | Ontario |
Canada | Cancer Centre of Southeastern Ontario at Kingston | Kingston | Ontario |
Canada | London Regional Cancer Program | London | Ontario |
Canada | Hopital Maisonneuve-Rosemont | Montreal | Quebec |
Canada | McGill University - Dept. Oncology | Montreal | Quebec |
Canada | Ottawa Health Research Institute - General Division | Ottawa | Ontario |
Canada | CHUQ-Pavillon Hotel-Dieu de Quebec | Quebec City | Quebec |
Canada | Allan Blair Cancer Centre | Regina | Saskatchewan |
Canada | Atlantic Health Sciences Corporation | Saint John | New Brunswick |
Canada | Saskatoon Cancer Centre | Saskatoon | Saskatchewan |
Canada | Centre hospitalier universitaire de Sherbrooke | Sherbrooke | Quebec |
Canada | Dr. H. Bliss Murphy Cancer Centre | St. John's | Newfoundland and Labrador |
Canada | Northeast Cancer Center Health Sciences | Sudbury | Ontario |
Canada | BCCA - Fraser Valley Cancer Centre | Surrey | British Columbia |
Canada | Thunder Bay Regional Health Science Centre | Thunder Bay | Ontario |
Canada | Univ. Health Network-Princess Margaret Hospital | Toronto | Ontario |
Canada | BCCA - Vancouver Cancer Centre | Vancouver | British Columbia |
Canada | CancerCare Manitoba | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
NCIC Clinical Trials Group |
Canada,
Ringash J, Waldron JN, Siu LL, Martino R, Winquist E, Wright JR, Nabid A, Hay JH, Hammond A, Sultanem K, Hotte S, Leong C, El-Gayed AA, Naz F, Ramchandar K, Owen TE, Montenegro A, O'Sullivan B, Chen BE, Parulekar WR. Quality of life and swallowing with standard chemoradiotherapy versus accelerated radiotherapy and panitumumab in locoregionally advanced carcinoma of the head and neck: A phase III randomised trial from the Canadian Cancer Trials Group (HN.6). Eur J Cancer. 2017 Feb;72:192-199. doi: 10.1016/j.ejca.2016.11.008. Epub 2016 Dec 29. — View Citation
Siu LL, Waldron JN, Chen BE, Winquist E, Wright JR, Nabid A, Hay JH, Ringash J, Liu G, Johnson A, Shenouda G, Chasen M, Pearce A, Butler JB, Breen S, Chen EX, FitzGerald TJ, Childs TJ, Montenegro A, O'Sullivan B, Parulekar WR. Effect of Standard Radiother — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free Survival (PFS) Rate | The progression event is defined by first event of the following, Local-regional progression or recurrence Distant metastasis Non-protocol RT, chemotherapy, or biologic therapy without documentation of the site of failure Surgery of primary site with tumour present/unknown Neck dissection with tumour present/unknown, > 15 weeks from end of RT Death due to study cancer or from unknown causes or any other reason Number of patients with and without progression event will be reported. |
6.2 years | |
Secondary | Overall Survival Rate | Overall survival is defined as the time interval between the date of randomization to date of death from any cause (calculated in months). Otherwise, survival is censored at the last date that the patient is known to be alive. Number of death and alive patients will be reported. |
6.2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05808920 -
The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or reCurrent sqUamous cEll Carcinoma of the Head and Neck
|
||
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Active, not recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT03997643 -
Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04700475 -
Effect of Low Level Laser Therapy on Prevention of Radiotherapy Induced Xerostomia in Cancer Patients.
|
N/A | |
Withdrawn |
NCT04058145 -
AMD3100 Plus Pembrolizumab in Immune Checkpoint Blockade Refractory Head and Neck Squamous Cell Carcinoma
|
Phase 2 | |
Completed |
NCT02572869 -
Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps
|
||
Active, not recruiting |
NCT04474470 -
A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer
|
Phase 1/Phase 2 | |
Withdrawn |
NCT05073809 -
Photoacoustic Imaging of Head and Neck Tumours
|
||
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Active, not recruiting |
NCT03651570 -
Randomized Controlled Trial of a E-intervention to Help Patients Newly Diagnosed With Cancer Cope Better: Pilot Study
|
N/A | |
Recruiting |
NCT04930432 -
Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06016699 -
Immunological Function After Radiation With Either Proton or Photon Therapy
|
||
Terminated |
NCT03843554 -
Commensal Oral Microbiota in Head and Neck Cancer
|
N/A | |
Recruiting |
NCT05915572 -
Mulligan Technique on Shoulder Dysfunction
|
N/A | |
Completed |
NCT05897983 -
Tens and Rocabado Exercises on TMJ Dysfunction
|
N/A | |
Not yet recruiting |
NCT06289049 -
Heavy Strength Training in Head and Neck Cancer Survivors
|
Phase 2 | |
Withdrawn |
NCT05263648 -
Virtual Reality Software to Reduce Stress in Cancer Patients
|
N/A | |
Withdrawn |
NCT03238638 -
A Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy
|
Phase 2 |