Proton or Photon RT for Retroperitoneal Sarcomas (NCT01659203)
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
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Rush University Medical Center โ Chicago, Illinois
Age range: 18 Years
๐งช Interventions in This Study
- IG-IMPT (RADIATION)
- IG IMRT (RADIATION)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (10 Sites)
- Rush University Medical Center โ Chicago, Illinois
- Massachusetts General Hospital โ Boston, Massachusetts
- Dana-Farber Cancer Institute โ Boston, Massachusetts
- Mayo Clinic โ Rochester, Minnesota
- Washington University School of Medicine Siteman Cancer Center West County โ Creve Coeur, Missouri
- Washington University School of Medicine Siteman Cancer Center South County โ St Louis, Missouri
- Roswell Park Cancer Institute โ Buffalo, New York
- Duke University โ Durham, North Carolina
- MD Anderson Cancer Center โ Houston, Texas
- University of Utah โ Salt Lake City, Utah
๐ Contact the Study Coordinator
Phone: (617) 726-6876
Email: tdelaney@partners.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Retroperitoneal Sarcoma
- Repeat or Single Quadratus Lumborum Block for the Reduction of Opioid Prescriptions After Surgery in Retroperitoneal Sarcoma Patients ("RESQU-SARC" Trial) โ Houston, Texas
- Short Course Radiation Treatment for Patients With Primary or Locally Recurrent Retroperitoneal Sarcoma Prior to Surgery โ Boston, Massachusetts
- REtroperitoneal SArcoma Registry: an International Prospective Initiative โ Los Angeles, California
- Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma โ Birmingham, Alabama
- Proton-Spatially Fractionated Radiotherapy and Standard Radiation Therapy for the Treatment of Newly Diagnosed Retroperitoneal Soft Tissue Sarcoma โ Chicago, Illinois
Explore by condition: All Retroperitoneal Sarcoma clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.