PHASE III TRIAL TO PRESERVE THE LARYNX: INDUCTION CHEMOTHERAPY AND RADIATION THERAPY VERSUS CONCOMITANT CHEMOTHERAPY AND RADIATION THERAPY VERSUS RADIATION THERAPY
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.
Interventional
Primary Purpose: Treatment
Helmuth Goepfert, MD
Study Chair
M.D. Anderson Cancer Center
United States: Federal Government
CDR0000077756
NCT00002496
August 1992
Name | Location |
---|---|
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
CCOP - Colorado Cancer Research Program, Inc. | Denver, Colorado 80209-5031 |
Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur, Georgia 30033 |
CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis, Indiana 46202 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
New England Medical Center Hospital | Boston, Massachusetts 02111 |
CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Veterans Affairs Medical Center - East Orange | East Orange, New Jersey 07018-1095 |
CCOP - Northern New Jersey | Hackensack, New Jersey 07601 |
Hahnemann University Hospital | Philadelphia, Pennsylvania 19102-1192 |
University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |