Radiation Therapy Following Surgery in Treating Patients With Recurrent or Second Primary Cancer … (NCT00004226) | Clinical Trial Compass
UnknownPhase 1/2
Radiation Therapy Following Surgery in Treating Patients With Recurrent or Second Primary Cancer of the Head and Neck Following Previous Radiation Therapy
United StatesStarted 2000-05
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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:
* No…