Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT01659203

Proton or Photon RT for Retroperitoneal Sarcomas

Led by Massachusetts General Hospital · Updated on 2026-03-19

80

Participants Needed

10

Research Sites

786 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

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

Official Title

Proton or Photon RT for Retroperitoneal Sarcomas

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically proven primary soft tissue sarcoma of the retroperitoneum
  • Measurable disease
  • Life expectancy of greater than 2 years
Not Eligible

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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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

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Research Team

T

Thomas DeLaney, MD

CONTACT

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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