Sargramostim in Decreasing Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer
Sponsored by Radiation Therapy Oncology Group
About this trial
Last updated 13 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Trial Timing
Started 26 years ago
What is this trial about?
What are the Participation Requirements?
DISEASE CHARACTERISTICS: * Histologically confirmed head and neck carcinoma with planned external beam radiotherapy to include 50% of oropharynx, oral cavity, or both] * Planned external beam radiotherapy of 60-70 Gy total dose to the primary tumor or standard ports for an unknown primary tumor * Neck metastases from an unknown primary allowed if radiotherapy planned to at least 50% of the salivary gland at a dose of at least 50 Gy * No T1-T2 glottic tumors * No residual oral/oropharyngeal injury from prior chemotherapy PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No allergy or idiosyncratic response to sargramostim (GM-CSF) * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * No concurrent chemotherapy other than cisplatin Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * No prior radiotherapy to the head and neck Surgery: * Not specified Other: * No concurrent enrollment on other RTOG head and neck studies * No concurrent oral care medications (e.g., amifostine, chlorhexidrine gluconate, sucralfate, or benzydamine HCl) during study radiotherapy * No concurrent selective oral cavity decontamination (e.g., IB-367) during study radiotherapy
