Radiation Before Surgery for Retroperitoneal Sarcoma Tumors
Tests proton or photon radiation before surgery in adults with retroperitoneal sarcoma.
Plain-language title generated from the registry record
Registry title: Proton or Photon RT for Retroperitoneal Sarcomas
Key facts
- Where
- Boston, Buffalo, Chicago, Creve Coeur, Durham, Houston, Rochester, Salt Lake City, and St Louis, United StatesSee the 10 sites
- Phase
- Phase 1/2
Where in United States
- Dana-Farber Cancer InstituteBoston, United StatesTaking people
- Massachusetts General HospitalBoston, United StatesTaking people
- Roswell Park Cancer InstituteBuffalo, United StatesTaking people
- Rush University Medical CenterChicago, United StatesTaking people
- Washington University School of Medicine Siteman Cancer Center West CountyCreve Coeur, United StatesTaking people
- Duke UniversityDurham, United StatesTaking people
- MD Anderson Cancer CenterHouston, United StatesTaking people
- Mayo ClinicRochester, United StatesTaking people
- University of UtahSalt Lake City, United StatesTaking people
- Washington University School of Medicine Siteman Cancer Center South CountySt Louis, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Massachusetts General Hospital
- Trial code
- NCT01659203
- Record updated
- 31 July 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Histologically proven primary soft tissue sarcoma of the retroperitoneum; Measurable disease; Life expectancy of greater than 2 years.
Exclusion: Prior radiation therapy for retroperitoneal sarcoma; Chemotherapy within 4 weeks prior to entering study; Receiving other investigational agents; 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; Pregnant or breastfeeding; Other types of sarcomas.