This clinical trial studies the safety and side effects of giving hypofractionated radiation therapy before surgery in treating patients with soft tissue sarcoma of the area in the back of the abdomen behind the tissue that lines the abdominal wall and covers most of the organs in the abdomen (retroperitoneal) that can be removed by surgery (resectable). Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving hypofractionated radiation therapy before surgery may be safe and may make the tumor smaller.
Additional locations may be listed on ClinicalTrials.gov for NCT06812052.
Locations matching your search criteria
United States
Massachusetts
Boston
Brigham and Women's HospitalStatus: Active
Contact: Miranda B Lam
Phone: 617-732-7948
Dana-Farber Cancer InstituteStatus: Active
Contact: Miranda B Lam
Phone: 617-732-7948
PRIMARY OBJECTIVE:
I. To determine the safety of moderately hypofractionated radiation in the treatment of primary and locally recurrent retroperitoneal sarcoma (RPS), based on the evaluation of acute radiation-related toxicity profile of each participant (30-day radiation toxicity).
SECONDARY OBJECTIVES:
I. To assess the peri-operative surgical complication rate.
II. To assess the long-term toxicity profiles.
III. To determine the local recurrence free survival.
IV. To determine the progression free survival.
V. To determine overall survival.
VI. To examine circulating tumor deoxyribonucleic acid (ctDNA) levels during treatment and follow up.
OUTLINE:
Patients undergo hypofractionated intensity modulated radiation therapy (IMRT) daily on weekdays for 15 treatment fractions over approximately 3 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care (SOC) surgery 4-12 weeks after completion of hypofractionated IMRT. Patients also undergo chest computed tomography (CT) and abdominal and pelvic CT or magnetic resonance imaging (MRI) throughout the study. In addition, patients may optionally undergo collection of blood samples throughout the study.
After completion of study treatment, patients are followed up at 3-4 months and then twice yearly for up to 5 years.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorMiranda B Lam