Spots Global Cancer Trial Database for Testing the Safety of Giving a Standard Dose of Radiation Over a Shorter Period of Time for Patients Who Had Surgery for Intermediate-Risk Head and Neck Cancer

Study Description

Brief Summary: This phase I trial is looking to determine if hypofractionated radiation therapy can be given safely after surgery for intermediate-risk head and neck cancer.

Detailed Description: PRIMARY OBJECTIVE: I. To determine if a hypofractionated postoperative radiotherapy (H-PORT) schedule for patients with intermediate-risk head and neck cancer (squamous cell carcinoma of the oral cavity, oropharynx, or larynx) who have undergone surgery is safe and feasible for further evaluation in a phase II clinical trial. SECONDARY OBJECTIVES: I. To assess H-PORT treatment-related and unrelated adverse events during treatment and within one year after treatment completion. II. To assess H-PORT tolerability and compliance, as measured by treatment interruptions and discontinuations, and to assess the reasons for those modifications. ARM I: Patients undergo surgery per standard of care followed by hypofractionated radiotherapy. Patients receive 50 Gy over 4 weeks (i.e., 2.5 Gy per day x 20 fractions). Radiation therapy should start after there is adequate healing and no evidence of gross residual/recurrent cancer. Patients are followed up at 1 month, 3 months, 6 months and 12 months post H-PORT therapy.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial