Recruiting
Phase 1
Phase 2

Proton & Photon RT

Sponsor:

Massachusetts General Hospital

Code:

NCT01659203

Conditions

Retroperitoneal Sarcoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

IG-IMPT

IG IMRT

Study Details

Brief 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.

Conditions

Retroperitoneal Sarcoma

Study ID

NCT01659203

Start date

Dec, 2012

Status verified date

Jul, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Arm IMPT

IG-IMPT with SIB to the high risk margin

experimental: Treatment Arm IMRT

IG IMRT with SIB to the high risk margin

Interventions

IG-IMPT

Daily, Monday-Friday for about 6 weeks

IG IMRT

Daily, Monday-Friday for about 6 weeks

Primary outcome measure

  • Phase I: Determine MTD [ Time Frame: 2 years ]
  • Phase II: Determine Local Control Rate [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Locations

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Dian Wang, MD

dian_wang@rush.edu

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Principal Investigator:

Thomas DeLaney, MD

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Elizabeth Baldini, MD, MPH

6177326310ebaldini@partners.org

Principal Investigator:

Elizabeth Baldini, MD, MPH

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55902

Contacts

Ivy Peterson, MD

petersen.ivy@mayo.edu

Washington University School of Medicine Siteman Cancer Center West County

Recruiting

Creve Coeur, Missouri, United States, 63141

Contacts

Jeff Michalski, MD

jmichalski@radonc.wustl.edu

Washington University School of Medicine Siteman Cancer Center South County

Recruiting

St Louis, Missouri, United States, 63129

Contacts

Jeff Michalski, MD

jmichalski@radonc.wustl.edu

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Principal Investigator:

Varun Chowdhry, MD

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Trey Blazer, MD

trey.blazer@duke.edu

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Andrew Bishop, MD

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Ying Hitchcock, MD

ying.hitchcock@hci.utah.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Keywords

  • extraskeletal chondrosarcoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-07-31.