Clinical trial Recruiting at 10 sites Phase1; Phase2 Interventional Ages 18 and up

Comparing proton and photon radiation for treating retroperitoneal sarcomas

Official title: Phase I/II Trial of Pre-Operative Image Guided Intensity Modulated Proton Radiation Therapy (IMPT) or Photon (IMRT) With Simultaneously Integrated Boost to the High Risk Margin for Retroperitoneal Sarcomas

Run by Massachusetts General Hospital · NCT01659203 · Data updated 2026-11-12

This study is testing whether proton beam radiation is safer and more effective than regular radiation for treating patients with retroperitoneal sarcomas before their surgery.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment80 (estimated)
SponsorMassachusetts General Hospital
Academic / other
Drugs / interventionsChemotherapy, radiation
Locations10 sites (Chicago, Illinois and 9 other locations)
StatusRecruiting
StartedDecember 2012
Main results expectedJune 30, 2027
Study endsDecember 31, 2027
Registry record updatedJuly 31, 2026
Trial IDNCT01659203 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals with histologically proven primary soft tissue sarcoma of the retroperitoneum and a life expectancy of over two years.

Probably not a fit

Patients with prior radiation therapy for retroperitoneal sarcoma or those with multifocal disease or metastases may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and appropriate dosing of proton beam radiation therapy and intensity-modulated radiation therapy (IMRT) for patients with retroperitoneal sarcomas. Participants will receive radiation therapy daily for about six weeks before undergoing surgery to remove their tumors. The study aims to minimize damage to normal tissue while effectively targeting the tumors. Additionally, blood samples may be collected for further genomic analysis.

Why it matters

Potential benefit: If successful, this study could lead to safer and more effective radiation treatment options for patients with retroperitoneal sarcomas.

How similar studies have gone: Other studies have shown promise with proton therapy in various cancers, suggesting potential for success in this novel application for retroperitoneal sarcomas.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Rush University Medical Center
    Chicago, Illinois, United States
    Recruiting
  • Massachusetts General Hospital
    Boston, Massachusetts, United States
    Recruiting
  • Dana-Farber Cancer Institute
    Boston, Massachusetts, United States
    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
Show 4 more locations
  • Roswell Park Cancer Institute
    Buffalo, New York, United States
    Recruiting
  • Duke University
    Durham, North Carolina, United States
    Recruiting
  • MD Anderson Cancer Center
    Houston, Texas, United States
    Recruiting
  • University of Utah
    Salt Lake City, Utah, United States
    Recruiting

Study contacts

  • Principal investigator: Thomas F. DeLaney, M.D. — Massachusetts General Hospital
  • Study coordinator: Thomas DeLaney, MD
  • Email: tdelaney@partners.org
  • Phone: 617-726-6876

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.