Radiation Therapy Following Surgery in Treating Patients With Recurrent or Second Primary Cancer of the Head and Neck Following Previous Radiation Therapy
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|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|