Clinical Trial - NCT01659203

Proton or Photon RT for Retroperitoneal Sarcomas

Recruiting

Sponsor: Massachusetts General Hospital

Collaborators: Dana-Farber Cancer Institute, Roswell Park Cancer Institute, National Cancer Institute (NCI), Duke University, Rush University Medical Center, University of Utah, Washington University School of Medicine, Mayo Clinic

Information provided by (Responsible party): Principal Investigator Massachusetts General Hospital Tom DeLaney, MD Principal Investigator

ClinicalTrials.gov Identifier: NCT01659203

Protocol Info

Short Description: Phase I/II Pre-Operative IMPT with Simultaneously Integrated Boost to the High Risk Margin for Retroperitoneal Sarcomas
Long Description: Phase I/II Trial of Pre-Operative Image Guided Intensity Modulated Proton Radiation Therapy (IMPT) with Simultaneously Integrated Boost to the High Risk Margin for Retroperitoneal Sarcomas
MGH Status: Open
Sponsor: DF/HCC
Disease Program: Proton

Next Steps


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Purpose

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.
Condition Title Intervention Phase
Retroperitoneal Sarcoma IG-IMPT IG IMRT Phase 1/Phase 2
Study Type Interventional
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

Primary Outcome Measures

Phase I: Determine MTD [Time Frame: 2 years] [Designated as safety issue: ]

Phase II: Determine Local Control Rate [Time Frame: 2 years] [Designated as safety issue: ]


Secondary Outcome Measures

Overall Survival [Time Frame: 2 years] [Designated as safety issue: ]

Pathologic Response [Time Frame: 2 years] [Designated as safety issue: ]

Tumor Response [Time Frame: 2 years] [Designated as safety issue: ]

Progression-Free Survival Times [Time Frame: 2 years] [Designated as safety issue: ]

Estimated Enrollment: 80
Study Start Date: December 2012
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: August 2020
Arms Assigned Interventions

Experimental:Treatment Arm IMPT

IG-IMPT with SIB to the high risk margin
Radiation:IG-IMPT
Daily, Monday-Friday for about 6 weeks

Experimental:Treatment Arm IMRT

IG IMRT with SIB to the high risk margin
Radiation:IG IMRT
Daily, Monday-Friday for about 6 weeks

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01659203

Locations

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

Sponsors and Collaborators

Massachusetts General Hospital

Dana-Farber Cancer Institute

Roswell Park Cancer Institute

National Cancer Institute (NCI)

Duke University

Rush University Medical Center

University of Utah

Washington University School of Medicine

Mayo Clinic

More Information

No publications provided

Responsible Party: Principal Investigator Massachusetts General Hospital Tom DeLaney, MD Principal Investigator
ClinicalTrials.gov Identifier: NCT01659203
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Massachusetts General Hospital:

extraskeletal chondrosarcoma

Additional relevant MeSH terms:

Sarcoma

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on April 09, 2020