Actively Recruiting
Phase I/II Trial of Pre-Operative Image Guided Intensity Modulated Proton Radiation Therapy or Photon Therapy With Integrated Boost for Retroperitoneal Sarcomas
Led by Massachusetts General Hospital · Updated on 2026-03-19
80
Participants Needed
10
Research Sites
26 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
D
Dana-Farber Cancer Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying retroperitoneal sarcomas, which are soft tissue tumors located at the back of the abdomen. This Phase I/II clinical trial aims to test the safety and determine the appropriate dose of radiation therapy using proton beam or intensity modulated radiation therapy (IMRT) before surgery. The study focuses on delivering targeted radiation to reduce side effects compared to traditional radiation given after surgery. Participants will receive either image-guided intensity modulated proton therapy (IG-IMPT) or image-guided IMRT daily, Monday through Friday, for about six weeks. Radiation planning involves a CT scan to precisely target the tumor. Higher radiation doses will be given to areas of the tumor identified as higher risk, while the rest of the tumor receives a standard dose. Treatment is delivered as outpatient therapy. During the study, participants will have weekly visits with the study doctor to monitor side effects and health. Before surgery, imaging and blood tests will assess overall health and treatment effects. Follow-up visits occur within one month after surgery, four months after surgery, and then twice yearly for five years, followed by yearly visits for life. The main goal is to find the highest safe radiation dose and evaluate local tumor control over two years.
CONDITIONS
Brief Title
Proton or Photon RT for Retroperitoneal Sarcomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically proven primary soft tissue sarcoma of the retroperitoneum
- Measurable disease
- Life expectancy of greater than 2 years
You will not qualify if you...
- Prior radiation therapy for retroperitoneal sarcoma
- Pregnant or breastfeeding
- Chemotherapy within 4 weeks prior to entering study
- Receiving other investigational agents
- Other types of sarcomas
- Multifocal disease, lymph node or distant metastases
- History of sensitivity to radiation therapy
- Uncontrolled intercurrent illness
- History of a different invasive malignancy within the past 3 years
- HIV positive on combination anti-retroviral therapy
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - About 6 weeks
Participants receive daily radiation therapy Monday through Friday for about six weeks as outpatient treatment. Weekly visits with the study doctor include assessments of medical history, vital signs, body weight, and side effects.
Weekly visits during radiation therapy plus daily treatment visits Monday through Friday
Duration - Up to surgery date after treatment
After completing radiation therapy, participants are assessed for side effects before surgery including imaging and blood tests.
1 visit before surgery
Duration - Up to 5 years and beyond
Participants have follow-up visits after surgery to monitor health and side effects, including medical assessments and imaging.
1 visit within one month post-discharge, 1 visit four months after surgery, then twice yearly for 5 years, then yearly thereafter
Trial Site Locations
Total: 10 locations
1
Rush University Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
4
Mayo Clinic
Rochester, Minnesota, United States, 55902
Actively Recruiting
5
Washington University School of Medicine Siteman Cancer Center West County
Creve Coeur, Missouri, United States, 63141
Actively Recruiting
6
Washington University School of Medicine Siteman Cancer Center South County
St Louis, Missouri, United States, 63129
Actively Recruiting
7
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
8
Duke University
Durham, North Carolina, United States, 27710
Actively Recruiting
9
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
10
University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
T
Thomas DeLaney, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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