Radiation Therapy With or Without Chemotherapy in Treating Patients With Advanced Cancer of the Larynx
- Conditions
- Head and Neck Cancer
- Registration Number
- NCT00002496
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
CCOP - Carle Cancer Center
πΊπΈUrbana, Illinois, United States
CCOP - Kalamazoo
πΊπΈKalamazoo, Michigan, United States
Beth Israel Deaconess Medical Center
πΊπΈBoston, Massachusetts, United States
Pretoria Academic Hospital
πΏπ¦Pretoria, South Africa
University of Pittsburgh Cancer Institute
πΊπΈPittsburgh, Pennsylvania, United States
CCOP - Illinois Oncology Research Association
πΊπΈPeoria, Illinois, United States
New England Medical Center Hospital
πΊπΈBoston, Massachusetts, United States
CCOP - Iowa Oncology Research Association
πΊπΈDes Moines, Iowa, United States
Hahnemann University Hospital
πΊπΈPhiladelphia, Pennsylvania, United States
Ireland Cancer Center
πΊπΈCleveland, Ohio, United States
CCOP - Colorado Cancer Research Program, Inc.
πΊπΈDenver, Colorado, United States
Indiana University Cancer Center
πΊπΈIndianapolis, Indiana, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
πΊπΈIndianapolis, Indiana, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
πΊπΈDecatur, Georgia, United States
CCOP - Northern New Jersey
πΊπΈHackensack, New Jersey, United States
Veterans Affairs Medical Center - East Orange
πΊπΈEast Orange, New Jersey, United States
CCOP - Metro-Minnesota
πΊπΈSaint Louis Park, Minnesota, United States
H. Lee Moffitt Cancer Center and Research Institute
πΊπΈTampa, Florida, United States