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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

RTOG-9901

Status

Completed

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

All Ages
All Sexes

Trial Timing

Started 26 years ago

What is this trial about?

RATIONALE: Sargramostim may lessen symptoms of mucositis in patients receiving radiation therapy for head and neck cancer. It is not yet known if sargramostim is more effective than no treatment in reducing mucositis caused by radiation therapy. PURPOSE: Randomized phase III trial to determine the effectiveness of sargramostim in decreasing mucositis in patients who are receiving radiation therapy for head and neck cancer.

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