Cisplatin and Radiation Therapy in Treating Patients With Stage IV Cancer of the Head and Neck

Phase 2

Completed

• Conditions: Head and Neck Cancer

• Registration Number: NCT00002932
• 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. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of cisplatin and radiation therapy in treating patients with stage IV cancer of the head and neck.

Detailed Description

OBJECTIVES: I. Determine the percentage of patients for whom a complete course of therapy can be administered using targeted supradose cisplatin chemoradiation in patients with squamous cell carcinoma of the head and neck. II. Determine the partial and complete response rate of cisplatin chemoradiation. III. Determine the incidence of adverse events using cisplatin chemoradiation therapy. IV. Determine the rate of disease-free survival and overall survival in these patients. V. Determine the incidence and pattern of recurrence in these patients. VI. Document quality of life measured by disease-specific instruments in these patients.

OUTLINE: All patients receive four courses of cisplatin on days 1, 8, 15, and 22 concurrent with radiotherapy. One course of chemotherapy consists of intra-arterial cisplatin given over 3-5 minutes. Radiotherapy is given 5 days a week for 7 weeks. This weekly cisplatin chemoradiation course will be repeated 4 times, providing recovery from toxicity is present. Dexamethasone is started the evening prior to cisplatin treatment, and continues until the morning following the procedure.

PROJECTED ACCRUAL: 60 patients will be enrolled.

Study Timeline

• Study Start: 1997-05
• Study First Submitted: 1999-11-01
• Primary Completion: 2001-03
• Study First Submitted QC: 2004-09-02
• Study First Posted: 2004-09-03
• Study Completion: 2005-03
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-19
• Last Update Posted: 2014-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (13)

University of California San Diego Cancer Center; 🇺🇸 La Jolla, California, United States

UCSF Cancer Center and Cancer Research Institute; 🇺🇸 San Francisco, California, United States

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States

MBCCOP - LSU Medical Center; 🇺🇸 New Orleans, Louisiana, United States

Marlene & Stewart Greenebaum Cancer Center, University of Maryland; 🇺🇸 Baltimore, Maryland, United States

CCOP - Baptist Cancer Institute; 🇺🇸 Memphis, Tennessee, United States

University of Tennessee, Memphis Cancer Center; 🇺🇸 Memphis, Tennessee, United States

Vanderbilt Cancer Center; 🇺🇸 Nashville, Tennessee, United States

Fletcher-Allen Health Care; 🇺🇸 Burlington, Vermont, United States

Green Mountain Oncology Group; 🇺🇸 Rutland, Vermont, United States

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