Sargramostim in Decreasing Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

+235 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Radiation Therapy Oncology Group

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Francis G. LeVeque, DDS

Principal Investigator

Barbara Ann Karmanos Cancer Institute

Eligibility Criteria

Inclusion Criteria

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

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