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Sponsors and Collaborators: |
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004226 |
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 | Intervention | Phase |
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Head and Neck Cancer |
Radiation: radiation therapy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
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 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma of the mucosa, recurrent (primary and/or nodal), or a second primary (positive or negative nodal), of one of the following:
Reirradiation field must overlap the previous field for a minimum of 3 cm in height, width, and length
No grade 3 or 4 toxicity for the following organ tissues:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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 |
Study ID Numbers: | CDR0000067467, UAB-RAD-9601, UAB-F970430006, NCI-G99-1656 |
Study First Received: | January 28, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00004226 History of Changes |
Health Authority: | United States: Federal Government |
recurrent squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the larynx |
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity recurrent squamous cell carcinoma of the oropharynx recurrent metastatic squamous neck cancer with occult primary |
Metastatic Squamous Neck Cancer With Occult Primary Neoplasms, Second Primary Laryngeal Carcinoma Head and Neck Neoplasms Epidermoid Carcinoma |
Squamous Cell Carcinoma Carcinoma, Squamous Cell Recurrence Hypopharyngeal Cancer Carcinoma |
Neoplasms Neoplasms by Site Neoplasms, Second Primary Head and Neck Neoplasms |