Proton or Photon RT for Retroperitoneal Sarcomas

Recruiting now · Phase 1/Phase 2

Conditions studied: Retroperitoneal Sarcoma

In brief

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.

Key facts

Study ID

NCT01659203

Run by

Massachusetts General Hospital

People needed

80

Starts

2012-12-01

Expected to finish

2027-12-31

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Rush University Medical Center — Chicago, Illinois, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• Washington University School of Medicine Siteman Cancer Center West County — Creve Coeur, Missouri, United States (enrolling)
• Washington University School of Medicine Siteman Cancer Center South County — St Louis, Missouri, United States (enrolling)
• Roswell Park Cancer Institute — Buffalo, New York, United States (enrolling)
• Duke University — Durham, North Carolina, United States (enrolling)
• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• University of Utah — Salt Lake City, Utah, United States (enrolling)

Full record on ClinicalTrials.gov

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