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Radiation Therapy Following Surgery in Treating Patients With Recurrent or Second Primary Cancer of the Head and Neck Following Previous Radiation Therapy

Head and Neck Cancer Clinical Trial

Official title:
Phase I/II Study of High Dose Limited Volume Postoperative Reirradiation in Recurrent or Second Primary Carcinoma of the Head and Neck

Clinical Trial Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy following surgery in treating patients who have recurrent or second primary cancer of the head and neck following previous radiation therapy.

Clinical Trial Description

OBJECTIVES:

- Determine the survival and local control in previously irradiated patients at high risk for local failure following regional resection of recurrent or second primary head and neck cancer.

- Determine the acute and late toxicities of this treatment in these patients.

- Determine the pattern of disease failure in these patients on this treatment.

- Determine any change in quality of life in these patients on this treatment.

OUTLINE: Patients receive fractionated doses of radiotherapy five times weekly for 6 weeks.

Quality of life is assessed prior to study, 2 months after radiotherapy, every 3 months for remainder of year 1, every 4 months for years 2-3, every 6 months for years 4-5, and then annually thereafter.

Patients are followed 2 months after radiotherapy, every 3 months for year 1, every 4 months for year 2, every 6 months for years 3-5, and then annually thereafter.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 5 years. ;

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00004226
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date May 2000
View Details
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