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Clinical trialNCT01659203RecruitingPhase 1/PHASE2Interventional

Proton or Photon RT for Retroperitoneal Sarcomas

SponsorMassachusetts General HospitalEnrollment80Retroperitoneal Sarcoma
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

10 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Rush University Medical Center

    Chicago, Illinois, United States

    Recruiting
  • Dana-Farber Cancer Institute

    Boston, Massachusetts, United States

    Elizabeth Baldini, MD, MPH
    Recruiting
  • Massachusetts General Hospital

    Boston, Massachusetts, United States

    Thomas DeLaney, MD
    Recruiting
  • Mayo Clinic

    Rochester, Minnesota, United States

    Recruiting
  • Washington University School of Medicine Siteman Cancer Center West County

    Creve Coeur, Missouri, United States

    Recruiting
  • Washington University School of Medicine Siteman Cancer Center South County

    St Louis, Missouri, United States

    Recruiting
  • Roswell Park Cancer Institute

    Buffalo, New York, United States

    Varun Chowdhry, MD
    Recruiting
  • Duke University

    Durham, North Carolina, United States

    Recruiting
  • Md Anderson Cancer Center

    Houston, Texas, United States

    Andrew Bishop, MD
    Recruiting
  • University of Utah

    Salt Lake City, Utah, United States

    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Dec 2012
Primary completion
30 Jun 2027
Completion
31 Dec 2027
Last update posted
31 Jul 2026
Registered enrollment
80
Registry id
NCT01659203

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.