This trial is active, not recruiting.

Condition head and neck cancer
Treatment radiation therapy
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

Study Design

Primary purpose treatment

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).