Trial Information

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

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.