Head and Neck Cancer Clinical Trial
Official title:
PHASE III TRIAL TO PRESERVE THE LARYNX: INDUCTION CHEMOTHERAPY AND RADIATION THERAPY VERSUS CONCOMITANT CHEMOTHERAPY AND RADIATION THERAPY VERSUS RADIATION THERAPY
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor
cells. It is not yet known if chemotherapy plus radiation therapy is more effective than
radiation therapy alone in treating patients with advanced cancer of the larynx.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with
or without chemotherapy in treating patients with advanced cancer of the larynx.
OBJECTIVES: I. Compare, in a phase III setting, overall and disease-free survival with
preservation of laryngeal function in patients with stage III/IV squamous cell carcinoma of
the glottic and supraglottic larynx treated with cisplatin/fluorouracil (CDDP/5-FU) followed
by radiotherapy vs. concomitant radiotherapy plus CDDP vs. radiotherapy alone. II. Compare
the tumor response after completion of chemotherapy but prior to initiation of radiotherapy
with that following completion of radiotherapy and concurrent chemotherapy. III. Compare the
patterns of relapse (local and regional recurrence and distant metastasis) with these
treatments. IV. Compare the incidence of second primary tumors in patients treated on these
three regimens. V. Compare the acute and chronic adverse effects of these three regimens.
VI. Compare the morbidity experienced with neck dissection and/or laryngeal salvage surgery
following treatment with these regimens. VII. Compare quality of life of patients with
laryngeal preservation vs. patients requiring salvage laryngectomies. VIII. Compare the
quality of life of patients receiving radiotherapy alone vs. those receiving chemotherapy as
well.
OUTLINE: Randomized study. Patients on any arm, clinically staged N+ undergo neck dissection
following completion of radiotherapy. Arm I: 2-Drug Combination Chemotherapy followed by
Radiotherapy. Cisplatin, CDDP, NSC-119875; Fluorouracil, 5-FU, NSC-19893; followed by
regional irradiation using linear accelerators with photon energies of 1.25-6 MV, electron
energies of 8-17 MeV, or Co60. Arm II: Radiotherapy plus Single-Agent
Chemotherapy/Radiosensitization. Regional irradiation using equipment as in Arm I; plus
CDDP. Arm III: Radiotherapy. Regional irradiation using equipment as in Arm I.
PROJECTED ACCRUAL: 546 patients (182/arm) will be entered over approximately 3 years. If any
arm is clearly inferior in laryngectomy-free survival after 137 patients have completed 2
years of follow-up study, that arm will be closed to further accrual. A second interim
analysis will be conducted after 410 patients have completed 2 years of follow-up.
;
Primary Purpose: Treatment
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