Radiation Therapy With or Without Chemotherapy in Treating Patients With Advanced Head and Neck Cancer
Launched by CANCER RESEARCH UK · Jun 8, 2004
Trial Information
Current as of March 20, 2025
Completed
Keywords
ClinConnect Summary
OBJECTIVES: I. Determine whether the addition of methotrexate (MTX) or VBMF (vincristine/bleomycin/methotrexate/fluorouracil) to radiotherapy for advanced carcinoma of the head and neck (with or without primary surgery) influences locoregional control and prolongs survival. II. Determine whether an effect on locoregional control or survival is apparent when chemotherapy is given during or following radiotherapy and whether it is increased when chemotherapy is given at both times. III. Determine, in a special randomization of patients with cancer of the oral cavity or oropharynx, whether nec...
Gender
ALL
Eligibility criteria
- • DISEASE CHARACTERISTICS: Histologically confirmed squamous cell cancer of the head and neck suitable for treatment with radiotherapy T2, T3, or T4 primary lesions Any N No distant metastasis May also be anaplastic carcinoma, verrucous carcinoma, or transitional cell carcinoma (as of 1/97) No occult primaries (as of 1/97) No adenocarcinomas, lymphomas, or melanomas (as of 1/97) Synchronous head and neck tumors are eligible (tumor with the worse prognosis is entered into study) (as of 1/97) Patients receiving surgery to neck nodes only must be randomized as surgery patients (as of 1/97) Patients with tumors of the oral cavity or oropharynx may additionally elect randomization to nodal irradiation vs. no further therapy provided there is no second primary
- • PATIENT CHARACTERISTICS: Age: 75 and under for patients electing participation in the nodal vs. no nodal irradiation portion of the study Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Fit for any protocol treatment option Willing to receive any protocol treatment option Prior malignancy allowed provided the treating clinician considers the patient cured
- • PRIOR CONCURRENT THERAPY: Biologic therapy: No prior therapy Chemotherapy: No prior therapy Endocrine therapy: No prior therapy Radiotherapy: No prior therapy Surgery: Prior biopsy or excision allowed
Trial Officials
Jeffrey S. Tobias, MD
Study Chair
University College London Hospitals
About Cancer Research Uk
Cancer Research UK is a leading independent charity dedicated to advancing cancer research and improving patient outcomes. With a commitment to funding innovative studies and clinical trials, the organization collaborates with researchers, healthcare professionals, and institutions to drive breakthroughs in cancer prevention, diagnosis, and treatment. By supporting a wide range of research initiatives, Cancer Research UK aims to translate scientific discoveries into effective therapies, enhance public awareness, and ultimately reduce the impact of cancer on individuals and society. Their rigorous approach and dedication to excellence position them at the forefront of the fight against cancer globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Brighton, England, United Kingdom
London, England, United Kingdom
Plymouth, England, United Kingdom
Belfast, Northern Ireland, United Kingdom
Indore, , India
Westcliff On Sea, England, United Kingdom
Belfast, Northern Ireland, United Kingdom
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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