Proton or Photon RT for Retroperitoneal Sarcomas

March 16, 2026 updated by: Kevin X. Liu, MD, DPHIL, Massachusetts General Hospital

Phase I/II Trial of Pre-Operative Image Guided Intensity Modulated Proton Radiation Therapy (IMPT) or Photon (IMRT) With Simultaneously Integrated Boost to the High Risk Margin for Retroperitoneal Sarcomas

This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational intervention. Phase I studies also try to define the appropriate dose of the investigational therapy to use for further studies. "Investigational" means that the intervention is still being studied and that research doctors are trying to find out more about it.

Retroperitoneal sarcomas are soft tissue tumors located at the far back of the abdomen. Typically, patients with retroperitoneal sarcomas either have surgery for the removal of their tumors alone, or have their tumors removed, followed by standard radiation therapy, or have pre-operative radiation followed by surgery. When conventional radiation therapy is delivered after surgery, it can damage normal tissue. In this study, you will undergo proton beam radiation therapy or IMRT before undergoing surgery for the removal of your tumor.

Proton radiation and IMRT are FDA approved radiation delivery systems. Protons are tiny particles with positive charge that can be controlled to travel a certain distance and stop inside the body. In theory, this allows better control of where the radiation dose is delivered as compared to photons. Since proton radiation is more targeted, it may help to reduce unwanted side effects from radiation.

In this study, a standard dose of radiation will be given to the majority of the tumor, while a simultaneously integrated boost of additional radiation will be given to certain areas of the tumor identified as higher risk. This means that a higher radiation dose will be given to the higher risk areas of the tumor.

The purpose of this study is to determine the highest dose of radiation therapy with protons or IMRT that can be delivered safely in patients with retroperitoneal sarcomas and the effectiveness of proton beam radiation therapy as an intervention for patients with retroperitoneal sarcomas.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

While being screened to determine eligibility for this study you may choose to participate in an additional blood sample for circulating DNA and a genomic DNA sample.

Since we are looking for the highest dose of Radiation Therapy that can be administered safely without severe or unmanageable side effects in participants that have retroperitoneal sarcomas, not everyone who participates in this research study will receive the same dose of study therapy. The dose you get will depend on the number of participants who have been enrolled in the study before you and how well they have tolerated their doses. Your study doctor will tell you which dose you will get.

Radiation planning is standard of care for all patients undergoing radiation therapy. Before you begin radiation therapy you will have a radiation planning CT scan of the tumor site. This scan will be in addition to the scans done in order to confirm your eligibility for this study. Doctors will use teh images from this scan to plan your radiation treatment.

You will receive radiation therapy every day Monday through Friday for about six weeks. You will receive study therapy as an outpatient. During radiation therapy, you will be seen by the study doctor once a week. Each visit will take about 15 minutes, and the following assessments will be completed: medical history, vital signs, body weight and assessments for any side effects you may be experiencing.

After the final dose of radiation therapy you will be assessed for side effects of radiation following your last dose and before surgery. The following assessments will be completed before your surgery at this visit: Chest CT, CT/MRI of the abdomen/pelvis and routine blood tests to check for overall health.

You will be seen for a follow-up visit within one month of discharge following surgery and again four months after the surgery. At the first follow-up visit, the following assessment will be completed: medical history, vital signs and body weight, questions about side effects and routine blood tests to check for overall health. At the four month follow up visit the following assessment will be completed: medical history, vital signs and body weight, chest CT and abdominal/pelvic CT.

After your four month follow-up visit, you will be seen twice yearly following radiation for the first five years and then once a year for the rest of your life.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • Thomas DeLaney, MD
        • Contact:
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Dana-Farber Cancer Institute
        • Principal Investigator:
          • Elizabeth Baldini, MD, MPH
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55902
    • Missouri
      • Creve Coeur, Missouri, United States, 63141
        • Recruiting
        • Washington University School of Medicine Siteman Cancer Center West County
        • Contact:
      • St Louis, Missouri, United States, 63129
        • Recruiting
        • Washington University School of Medicine Siteman Cancer Center South County
        • Contact:
    • New York
      • Buffalo, New York, United States, 14263
    • North Carolina
      • Durham, North Carolina, United States, 27710
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Contact:
          • Andrew Bishop, MD
        • Principal Investigator:
          • Andrew Bishop, MD
    • Utah
      • Salt Lake City, Utah, United States, 84112

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically proven primary soft tissue sarcoma of the retroperitoneum
  • Measurable disease
  • Life expectancy of greater than 2 years

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Arm IMPT
IG-IMPT with SIB to the high risk margin
Radiation: IG-IMPT
Daily, Monday-Friday for about 6 weeks
Experimental: Treatment Arm IMRT
IG IMRT with SIB to the high risk margin
Radiation: IG IMRT
Daily, Monday-Friday for about 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase I: Determine MTD
Time Frame: 2 years
To determine the maximum tolerated dose (MTD) of preoperative IG-IMPT or IMRTwith simultaneously integrated boost to the high risk margin of retroperitoneal sarcoma. This is mainly based on evaluation of acute toxicity profile of each participant.
2 years
Phase II: Determine Local Control Rate
Time Frame: 2 years
To determine the local control rate after the protocol treatment (IG-IMPT or IMRT MTD with simultaneously integrated boost to the high risk margin) followed by surgical resection.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 2 years
To estimate overall survival
2 years
Pathologic Response
Time Frame: 2 years
To estimate pathologic response (percentage of necrosis and margin status, especially status of the high-risk margin)
2 years
Tumor Response
Time Frame: 2 years
To estimate the tumor response through the comparison of CT imaging before and after the protocol treatment.
2 years
Progression-Free Survival Times
Time Frame: 2 years
To assess progression-free survival times relative to surrogate biological endpoints in tissue and blood in each participant
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

National Cancer Institute (NCI)
Mayo Clinic
Washington University School of Medicine
Dana-Farber Cancer Institute
Duke University
Rush University Medical Center
Roswell Park Cancer Institute
University of Utah

Investigators

  • Principal Investigator: Thomas F. DeLaney, M.D., Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

August 3, 2012

First Submitted That Met QC Criteria

August 3, 2012

First Posted (Estimated)

August 7, 2012

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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