Actively Recruiting
Prospective Phase I Trial of Hypofractionated Radiation Therapy in Retroperitoneal Sarcoma
Led by Brigham and Women's Hospital · Updated on 2025-10-14
6
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of a shorter course of radiation therapy, called moderately hypofractionated radiation, for treating primary and locally recurrent retroperitoneal sarcoma (RPS). This phase I trial focuses on assessing the acute side effects related to radiation within 30 days after treatment. The study is sponsored by Brigham and Women's Hospital and aims to better understand the toxicity profile of this radiation approach. Participants receive hypofractionated radiation therapy, with a dose of 2.85 Gy given over 15 sessions totaling 42.75 Gy. If multiple patients experience dose-limiting toxicities, the radiation dose may be lowered to 2.7 Gy over 15 sessions (40.5 Gy). This treatment is delivered before surgery to the retroperitoneal tumor, and it involves a shorter radiation schedule than traditional therapies. During the study, participants will be closely monitored for side effects from radiation from enrollment until 30 days after completing treatment. Evaluations include imaging scans such as CT or MRI to confirm measurable disease, and assessments of kidney, bone marrow, liver function, and overall health status. Safety and toxicity data will guide dose adjustments, and participants will be followed until the end of the study period in November 2026.
CONDITIONS
Brief Title
Short Course Radiation Treatment for Patients With Primary or Locally Recurrent Retroperitoneal Sarcoma Prior to Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have a confirmed soft tissue sarcoma in the retroperitoneal or infra-peritoneal pelvic areas
- Measurable disease by CT or MRI scans according to RECIST 1.1
- Must have primary, locally recurrent, or metastatic disease needing treatment of the retroperitoneal mass
- Tumor must be suitable for radiotherapy and surgery with expected complete or near-complete resection
- Age 18 years or older
- ECOG performance status of 2 or less
- No history of bowel obstruction, mesenteric ischemia, or severe chronic inflammatory bowel disease
- Normal kidney function with creatinine clearance of at least 50 mL/min
- Normal bone marrow and liver function (specified blood counts and bilirubin levels)
- Women able to have children must have a negative pregnancy test within 3 weeks before treatment
- Use of adequate contraception if capable of childbearing
- Ability and willingness to sign informed consent
You will not qualify if you...
- Sarcoma originating from bone or abdominal/gynecological organs
- Certain histological subtypes including gastrointestinal stromal tumor, rhabdomyosarcoma, primitive neuroectodermal tumor, osteosarcoma, chondrosarcoma, aggressive fibromatosis, sarcomatoid or metastatic carcinoma
- Prior radiation therapy to the retroperitoneal sarcoma area
- Previous abdominal or pelvic radiation for other diseases
- Recent chemotherapy or immunotherapy within 6 weeks before radiation
- Pregnant women
- HIV-positive individuals on combination antiretroviral therapy
- Prior invasive malignancy unless approved by investigators and principal investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 weeks
Participants receive a hypofractionated course of radiation therapy prior to surgery. The initial radiation dose is 2.85 Gy given in 15 fractions, with a possible dose de-escalation to 2.7 Gy x 15 fractions if dose-limiting toxicities occur.
15 visits for radiation therapy
Duration - 30 days after radiation treatment completion
Participants are monitored for side effects related to radiation therapy for 30 days after completing treatment.
Multiple follow-up visits during 30 days
Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital / Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02446
Actively Recruiting
Research Team
M
Miranda Lam
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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