Phase II Study of 5-Day Hypofractionated Preoperative Radiation Therapy for Soft Tissue Sarcomas: Expansion Cohort

Launched by JONSSON COMPREHENSIVE CANCER CENTER · Mar 2, 2016

Keywords

ClinConnect Summary

This clinical trial is studying a type of radiation therapy called hypofractionated radiation therapy for patients with recurrent soft tissue sarcomas. This treatment delivers higher doses of radiation over a shorter time, which could potentially kill more cancer cells while causing fewer side effects. The goal of the trial is to see how well this treatment works before surgery for patients who have soft tissue sarcomas in their arms, legs, or trunk.

To participate in the trial, patients should have a confirmed diagnosis of soft tissue sarcoma that can be surgically removed, and they should not have received radiation therapy before. Participants need to be between 65 and 74 years old and in good overall health, with certain performance status scores (which measure how well they can carry out daily activities). During the trial, participants will receive the new type of radiation therapy for five days, and the doctors will monitor how they respond to the treatment and any side effects they may experience. This trial is currently looking for volunteers, and it's an opportunity to contribute to research that may help improve treatment for soft tissue sarcomas in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histologically confirmed soft tissue sarcoma of the extremity/trunk
• • Intermediate or high grade sarcoma
• • Resectable primary lesion (patients with pre-existing metastasis will be included if their primary is still going to be resected)
• • Recurrent, any grade, no previous radiation therapy
• • Karnofsky performance status (KPS) \>= 70 or Eastern Cooperative Oncology Group (ECOG) 0 - 2
• • If a woman is of childbearing potential, a negative serum pregnancy test must be documented
• Exclusion Criteria:
• • Active treatment of a separate malignancy
• • History of prior irradiation to the area to be treated
• • Pre-operative chemotherapy (post-op acceptable)