RECRUITING

Proton or Photon RT for Retroperitoneal Sarcomas

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. 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.

Study Overview

Study Details

Study overview

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.

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

Proton or Photon RT for Retroperitoneal Sarcomas

Condition
Retroperitoneal Sarcoma
Intervention / Treatment

-

Contacts and Locations

Chicago

Rush University Medical Center, Chicago, Illinois, United States, 60612

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Boston

Dana-Farber Cancer Institute, Boston, Massachusetts, United States, 02115

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55902

Creve Coeur

Washington University School of Medicine Siteman Cancer Center West County, Creve Coeur, Missouri, United States, 63141

Saint Louis

Washington University School of Medicine Siteman Cancer Center South County, Saint Louis, Missouri, United States, 63129

Buffalo

Roswell Park Cancer Institute, Buffalo, New York, United States, 14263

Durham

Duke University, Durham, North Carolina, United States, 27710

Houston

MD Anderson Cancer Center, Houston, Texas, United States, 77030

Salt Lake City

University of Utah, Salt Lake City, Utah, United States, 84112

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Histologically proven primary soft tissue sarcoma of the retroperitoneum
  • * Measurable disease
  • * Life expectancy of greater than 2 years
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Massachusetts General Hospital,

Thomas F. DeLaney, M.D., PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

2025-08