Radiation Therapy Following Surgery in Treating Patients With Recurrent or Second Primary Cancer of the Head and Neck Following Previous Radiation Therapy
This trial is active, not recruiting.
|Condition||head and neck cancer|
|Phase||phase 1/phase 2|
|Sponsor||University of Alabama at Birmingham|
|Collaborator||National Cancer Institute (NCI)|
|Start date||May 2000|
|Trial identifier||NCT00004226, CDR0000067467, NCI-G99-1656, UAB-F970430006, UAB-RAD-9601|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Birmingham, AL||University of Alabama at Birmingham Comprehensive Cancer Center||no longer recruiting|
|Loma Linda, CA||Loma Linda University Cancer Institute at Loma Linda University Medical Center||no longer recruiting|
|Tampa, FL||Veterans Affairs Medical Center - Tampa (Haley)||no longer recruiting|
Male or female participants at least 18 years old.
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: - Oral cavity - Oropharynx - Hypopharynx - Larynx - Paranasal sinus - Neck disease of unknown origin - No distant metastases - No primary in the nasopharynx - Must have complete gross resection of disease - Must have positive final margins, soft tissue extension of primary, positive extracapsular extension of lymph node disease, or at least 4 positive nodes without extracapsular extension - Reirradiation field must overlap the previous field for a minimum of 3 cm in height, width, and length - At least 6 months since prior radiotherapy with an overlap volume of at least 45 Gy - No grade 3 or 4 toxicity for the following organ tissues: - RTOG grade 3 or 4 skin, subcutaneous tissue, larynx, joint, or RTOG grade 4 mucous membrane or bone from prior radiotherapy - Radiotherapy must begin within 6-12 weeks of surgery - Prior radiotherapy records must be available PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - At least 3 months Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - Not pregnant - No history of invasive malignancy that would be expected to cause death within 3 years PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics Surgery: - See Disease Characteristics
|Official title||Phase I/II Study of High Dose Limited Volume Postoperative Reirradiation in Recurrent or Second Primary Carcinoma of the Head and Neck|
|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.|
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