Radiation Therapy Following Surgery in Treating Patients With Recurrent or Second Primary Cancer of the Head and Neck Following Previous Radiation Therapy
|ClinicalTrials.gov Identifier: NCT00004226|
Recruitment Status : Unknown
Verified July 2004 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : December 4, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Radiation: radiation therapy||Phase 1 Phase 2|
- 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 Type :||Interventional (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|
|Study Start Date :||May 2000|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004226
|United States, Alabama|
|University of Alabama at Birmingham Comprehensive Cancer Center|
|Birmingham, Alabama, United States, 35294-3300|
|United States, California|
|Loma Linda University Cancer Institute at Loma Linda University Medical Center|
|Loma Linda, California, United States, 92354|
|United States, Florida|
|Veterans Affairs Medical Center - Tampa (Haley)|
|Tampa, Florida, United States, 33612|
|Study Chair:||James L. Pearlman, MD||H. Lee Moffitt Cancer Center and Research Institute|