RECRUITING

Proton or Photon RT for Retroperitoneal Sarcomas

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2012-12
Study Completion:2025-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01659203

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically proven primary soft tissue sarcoma of the retroperitoneum
  2. * Measurable disease
  3. * Life expectancy of greater than 2 years
  1. * Prior radiation therapy for retroperitoneal sarcoma
  2. * Pregnant or breastfeeding
  3. * Chemotherapy within 4 weeks prior to entering study
  4. * Receiving other investigational agents
  5. * Other types of sarcomas
  6. * Multifocal disease, lymph node or distant metastases
  7. * History of sensitivity to radiation therapy
  8. * Uncontrolled intercurrent illness
  9. * History of a different invasive malignancy within the past 3 years
  10. * HIV positive on combination anti-retroviral therapy

Contacts and Locations

Study Contact

Thomas DeLaney, MD
CONTACT
617-726-6876
tdelaney@partners.org

Principal Investigator

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

Study Locations (Sites)

Rush University Medical Center
Chicago, Illinois, 60612
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Mayo Clinic
Rochester, Minnesota, 55902
United States
Washington University School of Medicine Siteman Cancer Center West County
Creve Coeur, Missouri, 63141
United States
Washington University School of Medicine Siteman Cancer Center South County
Saint Louis, Missouri, 63129
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
Duke University
Durham, North Carolina, 27710
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
University of Utah
Salt Lake City, Utah, 84112
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2012-12
Study Completion Date2025-08

Study Record Updates

Study Start Date2012-12
Study Completion Date2025-08

Terms related to this study

Keywords Provided by Researchers

  • extraskeletal chondrosarcoma

Additional Relevant MeSH Terms

  • Retroperitoneal Sarcoma