Phase III Intergroup Trial of Surgery Followed by (1) Radiotherapy vs. (2) Radiochemotherapy For Resectable High Risk Squamous Cell Carcinoma of the Head and Neck
Overview
- Phase
- Phase 3
- Intervention
- low-LET electron therapy
- Conditions
- Head and Neck Cancer
- Sponsor
- Radiation Therapy Oncology Group
- Enrollment
- 459
- Locations
- 23
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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 whether radiation therapy plus cisplatin is more effective than radiation therapy alone in treating patients with head and neck cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus cisplatin with radiation therapy alone in treating patients with head and neck cancer that has been removed during surgery.
Detailed Description
OBJECTIVES: I. Evaluate locoregional control rates, patterns of first failure, and overall and disease-free survival in patients with advanced squamous cell carcinoma of the head and neck at high risk of locoregional recurrence who are treated postoperatively with concurrent cisplatin and radiotherapy. II. Compare the toxicity of concurrent chemoradiotherapy vs. radiotherapy alone in the postoperative setting. OUTLINE: Randomized study. Arm I: Radiotherapy. Involved-field irradiation using Co60, 1-6 MV photons, or electrons. Arm II: Radiotherapy plus Single-Agent Chemotherapy. Irradiation as in Arm I; plus Cisplatin, CDDP, NSC-119875. PROJECTED ACCRUAL: 438 patients will be entered over approximately 5 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Radiation therapy plus cisplatin
Radiation therapy - 60 Gy in 6 weeks (2 Gy once a day, 5 x a week) plus Cisplatin-100 mg/m2 i.v. on days 1,22 and 43 with radiation therapy.
Intervention: low-LET electron therapy
Radiation therapy
Radiation therapy - 60 Gy in 6 weeks (2 Gy once a day, 5 x a week)
Intervention: low-LET cobalt-60 gamma ray therapy
Radiation therapy
Radiation therapy - 60 Gy in 6 weeks (2 Gy once a day, 5 x a week)
Intervention: low-LET electron therapy
Radiation therapy
Radiation therapy - 60 Gy in 6 weeks (2 Gy once a day, 5 x a week)
Intervention: low-LET photon therapy
Radiation therapy plus cisplatin
Radiation therapy - 60 Gy in 6 weeks (2 Gy once a day, 5 x a week) plus Cisplatin-100 mg/m2 i.v. on days 1,22 and 43 with radiation therapy.
Intervention: chemotherapy
Radiation therapy plus cisplatin
Radiation therapy - 60 Gy in 6 weeks (2 Gy once a day, 5 x a week) plus Cisplatin-100 mg/m2 i.v. on days 1,22 and 43 with radiation therapy.
Intervention: cisplatin
Radiation therapy plus cisplatin
Radiation therapy - 60 Gy in 6 weeks (2 Gy once a day, 5 x a week) plus Cisplatin-100 mg/m2 i.v. on days 1,22 and 43 with radiation therapy.
Intervention: low-LET cobalt-60 gamma ray therapy
Radiation therapy plus cisplatin
Radiation therapy - 60 Gy in 6 weeks (2 Gy once a day, 5 x a week) plus Cisplatin-100 mg/m2 i.v. on days 1,22 and 43 with radiation therapy.
Intervention: low-LET photon therapy
Outcomes
Primary Outcomes
Not specified