RecruitingPhase 1Phase 2NCT01659203

Proton or Photon RT for Retroperitoneal Sarcomas

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


Sponsor

Massachusetts General Hospital

Enrollment

80 participants

Start Date

Dec 1, 2012

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of radiation therapy — proton therapy and conventional photon (X-ray) radiation — in people with primary soft tissue sarcoma (a type of cancer in the connective tissues) located in the back of the abdomen, to find out which approach provides better tumor control with fewer side effects. **You may be eligible if...** - You have been diagnosed with a primary soft tissue sarcoma in the retroperitoneum (the area behind the abdominal organs), confirmed by biopsy - Your cancer is measurable - Your life expectancy is more than 2 years **You may NOT be eligible if...** - You have previously had radiation therapy for this sarcoma - You are pregnant or breastfeeding - You have had chemotherapy within 4 weeks before entering the study - You are participating in another experimental drug trial - Your cancer has spread to lymph nodes or other organs - Your sarcoma has multiple separate locations - You are HIV-positive - You have had another type of invasive cancer within the past 3 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONIG-IMPT

Daily, Monday-Friday for about 6 weeks

RADIATIONIG IMRT

Daily, Monday-Friday for about 6 weeks


Locations(10)

Rush University Medical Center

Chicago, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University School of Medicine Siteman Cancer Center West County

Creve Coeur, Missouri, United States

Washington University School of Medicine Siteman Cancer Center South County

St Louis, Missouri, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Duke University

Durham, North Carolina, United States

MD Anderson Cancer Center

Houston, Texas, United States

University of Utah

Salt Lake City, Utah, United States

View Full Details on ClinicalTrials.gov

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NCT01659203


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