Radiation Therapy With or Without Chemotherapy in Treating Patients With Head and Neck Cancer That Has Been Removed During Surgery

Phase 3

Completed

• Conditions: Head and Neck Cancer
• Interventions: Radiation: low-LET cobalt-60 gamma ray therapy; Drug: chemotherapy; Radiation: low-LET electron therapy; Drug: cisplatin; Radiation: low-LET photon therapy

• Registration Number: NCT00002670
• Lead Sponsor: Radiation Therapy Oncology Group

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.

Study Timeline

• Study Start: 1995-09
• Study First Submitted: 1999-11-01
• Primary Completion: 2002-07
• Study First Submitted QC: 2004-06-09
• Study First Posted: 2004-06-10
• Study Completion: 2013-11
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-23
• Last Update Posted: 2014-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 459

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiation therapy	low-LET cobalt-60 gamma ray therapy	Radiation therapy - 60 Gy in 6 weeks (2 Gy once a day, 5 x a week)
Radiation therapy	low-LET electron therapy	Radiation therapy - 60 Gy in 6 weeks (2 Gy once a day, 5 x a week)
Radiation therapy plus cisplatin	chemotherapy	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.
Radiation therapy	low-LET photon therapy	Radiation therapy - 60 Gy in 6 weeks (2 Gy once a day, 5 x a week)
Radiation therapy plus cisplatin	low-LET cobalt-60 gamma ray therapy	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.
Radiation therapy plus cisplatin	low-LET electron therapy	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.
Radiation therapy plus cisplatin	low-LET photon therapy	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.
Radiation therapy plus cisplatin	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.

Trial Locations

Locations (23)

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States

Emory University Hospital - Atlanta; 🇺🇸 Atlanta, Georgia, United States

Veterans Affairs Medical Center - Atlanta (Decatur); 🇺🇸 Decatur, Georgia, United States

CCOP - Evanston; 🇺🇸 Evanston, Illinois, United States

CCOP - Illinois Oncology Research Association; 🇺🇸 Peoria, Illinois, United States

CCOP - Carle Cancer Center; 🇺🇸 Urbana, Illinois, United States

Indiana University Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

CCOP - Cedar Rapids Oncology Project; 🇺🇸 Cedar Rapids, Iowa, United States

CCOP - Iowa Oncology Research Association; 🇺🇸 Des Moines, Iowa, United States

CCOP - Kalamazoo; 🇺🇸 Kalamazoo, Michigan, United States

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