NCT00008398
Sargramostim in Decreasing Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer
PHASE3
COMPLETED
NCT00008398
INTERVENTIONAL
A Phase III Study to Test the Efficacy and Safety of GM-CSF to Reduce the Severity and Duration of Mucosal Injury and Pain (Mucositis) Associated With Curative Radiation Therapy in Head and Neck Cancer Patients
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.
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
Head and Neck Cancer
Oral Complications
Radiation Toxicity
- SUPPORTIVE_CARE
-
- Type: BIOLOGICAL
- Name: sargramostim
- Description:
- Arm Group Labels:
-
- Type: PROCEDURE
- Name: quality-of-life assessment
- Description:
- Arm Group Labels:
-
- Type: RADIATION
- Name: radiation therapy
- Description:
- Arm Group Labels:
- Radiation Therapy Oncology Group