Radiation Therapy With or Without Chemotherapy in Treating Patients With Advanced Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT00002476|
Recruitment Status : Completed
First Posted : June 9, 2004
Last Update Posted : August 2, 2013
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if radiation therapy plus chemotherapy is more effective than radiation therapy alone in treating patients with advanced head and neck cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without chemotherapy in treating patients with advanced head and neck cancer.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Biological: bleomycin sulfate Drug: fluorouracil Drug: leucovorin calcium Drug: methotrexate Drug: vincristine sulfate Radiation: low-LET cobalt-60 gamma ray therapy Radiation: low-LET photon therapy Radiation: radiation therapy||Phase 3|
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 neck irradiation improves locoregional control and survival.
OUTLINE: Randomized study. Patients without prior surgery are randomized 1:2 to Arms I:II-IV, while those with prior surgery are randomized 1:1 between Arms I and II only. Patients with tumors of the oral cavity or oropharynx may elect additional randomization between Arms V and VI and will receive irradiation of the primary according to the Manchester regimen. Arm I: Radiotherapy. Irradiation of the primary and/or lymph nodes according to 1 of 2 regimens (Manchester 3-week schedule or SECOG 6-week schedule) using megavoltage equipment. Arm II: Radiotherapy plus Concurrent Single-agent or 4-Drug Combination Chemotherapy with Leucovorin Rescue. Involved-field irradiation as in Arm I; plus Methotrexate, MTX, NSC-740; with Leucovorin calcium, CF, NSC-3590; or VBMF: Vincristine, VCR, NSC-67574; Bleomycin, BLEO, NSC-125066; MTX; Fluorouracil, 5-FU, NSC-19893; with CF. Arm III: Radiotherapy plus Subsequent Single-agent or 4-Drug Combination Chemotherapy with Leucovorin Rescue. Involved-field irradiation as in Arm I; plus MTX or VBMF; with CF. Arm IV: Radiotherapy plus Concurrent and Subsequent Single-agent or 4-Drug Combination Chemotherapy with Leucovorin Rescue. Involved-field irradiation as in Arm I; plus MTX or VBMF; with CF. Arm V: Radiotherapy. Neck node irradiation using megavoltage equipment. Arm VI: Observation. No nodal irradiation.
PROJECTED ACCRUAL: At least 1,000 patients will be entered.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase III Randomized Study of Radiotherapy Alone vs With Concurrent Chemotherapy With MTX or VBMF (VCR/BLEO/MTX/5-FU) vs Subsequent Chemotherapy vs Concurrent and Subsequent Chemotherapy in Patients With Advanced Head and Neck Cancer|
|Study Start Date :||January 1990|
|Actual Study Completion Date :||January 2010|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002476
|Indore, India, 452001|
|Royal Sussex County Hospital|
|Brighton, England, United Kingdom, BN2 5BE|
|Middlesex Hospital- Meyerstein Institute|
|London, England, United Kingdom, W1N 8AA|
|Plymouth, England, United Kingdom, PL6 8DH|
|Southend General Hospital|
|Westcliff-On-Sea, England, United Kingdom|
|Royal Victoria Hospital|
|Belfast, Northern Ireland, United Kingdom, BT12 6BJ|
|Belfast City Hospital Trust|
|Belfast, Northern Ireland, United Kingdom, BT8 8JR|
|Study Chair:||Jeffrey S. Tobias, MD||University College London Hospitals|