Radiation Therapy and Cisplatin in Treating Patients With Advanced Head and Neck Cancer

Phase 2

Completed

• Conditions: Head and Neck Cancer

• Registration Number: NCT00005088
• 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. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of radiation therapy and cisplatin in treating patients who have advanced head and neck cancer.

Detailed Description

OBJECTIVES: I. Determine the rate of local regional recurrence at one year in patients with advanced head and neck cancer treated with boost radiotherapy and cisplatin. II. Determine the feasibility of treatment delivery, patient tolerance, and acute and late toxicities in these patients on this regimen. III. Determine the overall survival, disease free survival, and distant relapse rates of these patients on this regimen.

OUTLINE: Patients receive fractionated radiotherapy 1-2 times daily over 5 consecutive days for 6 weeks, and cisplatin IV over 1-2 hours on days 1 and 22. Patients may undergo salvage surgery if biopsy proven cancer remains more than 3 months after treatment. Patients are followed every 3 months for 2 years, every 6 months for 3 years, then annually until death.

PROJECTED ACCRUAL: A total of 50-56 patients will be accrued for this study within 7 months.

Study Timeline

• Study Start: 2000-04
• Study First Submitted: 2000-04-06
• Primary Completion: 2002-01
• Study First Submitted QC: 2004-05-25
• Study First Posted: 2004-05-26
• Status Verified: 2013-11
• Last Update Submitted: 2020-10-21
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (258)

University of Alabama Comprehensive Cancer Center; 🇺🇸 Birmingham, Alabama, United States

Comprehensive Cancer Institute of Huntsville; 🇺🇸 Huntsville, Alabama, United States

Huntsville Hospital System; 🇺🇸 Huntsville, Alabama, United States

Mobile Infirmary Medical Center; 🇺🇸 Mobile, Alabama, United States

Urology Associates - Mobile AL; 🇺🇸 Mobile, Alabama, United States

MBCCOP - University of South Alabama; 🇺🇸 Mobile, Alabama, United States

Alabama Oncology, LLC; 🇺🇸 Montgomery, Alabama, United States

Radiation Oncology Associates of West Alabama; 🇺🇸 Tuscaloosa, Alabama, United States

Providence Cancer Therapy Center; 🇺🇸 Anchorage, Alaska, United States

Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

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