Proton or Photon RT for Retroperitoneal Sarcomas

Last updated: March 16, 2026
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting

Phase

1/2

Condition

Sarcoma

Treatment

IG-IMPT

IG IMRT

Clinical Study ID

NCT01659203
12-100
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically proven primary soft tissue sarcoma of the retroperitoneum

  • Measurable disease

  • Life expectancy of greater than 2 years

Exclusion

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 Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: IG-IMPT
Phase: 1/2
Study Start date:
December 01, 2012
Estimated Completion Date:
December 31, 2027

Study 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.

Connect with a study center

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • Rush University Medical Center

    Chicago 4887398, Illinois 4896861 60612
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Dana-Farber Cancer Institute

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55902
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester 5043473, Minnesota 5037779 55902
    United States

    Site Not Available

  • Washington University School of Medicine Siteman Cancer Center West County

    Creve Coeur, Missouri 63141
    United States

    Active - Recruiting

  • Washington University School of Medicine Siteman Cancer Center South County

    Saint Louis, Missouri 63129
    United States

    Site Not Available

  • Washington University School of Medicine Siteman Cancer Center South County

    St Louis, Missouri 63129
    United States

    Active - Recruiting

  • Washington University School of Medicine Siteman Cancer Center West County

    Creve Coeur 4382837, Missouri 4398678 63141
    United States

    Site Not Available

  • Washington University School of Medicine Siteman Cancer Center South County

    St Louis 4407066, Missouri 4398678 63129
    United States

    Site Not Available

  • Roswell Park Cancer Institute

    Buffalo, New York 14263
    United States

    Active - Recruiting

  • Roswell Park Cancer Institute

    Buffalo 5110629, New York 5128638 14263
    United States

    Site Not Available

  • Duke University

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Duke University

    Durham 4464368, North Carolina 4482348 27710
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84112
    United States

    Active - Recruiting

  • University of Utah

    Salt Lake City 5780993, Utah 5549030 84112
    United States

    Site Not Available

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