Proton or Photon RT for Retroperitoneal Sarcomas

NCT01659203 | Recruiting Phase 1 DMC

• 1 other identifier: 12-100
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Retroperitoneal Sarcoma

Keywords

extraskeletal chondrosarcoma

Outcome Measures

Primary Outcomes (2)

• Phase I: Determine MTD

  To determine the maximum tolerated dose (MTD) of preoperative IG-IMPT or IMRTwith simultaneously integrated boost to the high risk margin of retroperitoneal sarcoma. This is mainly based on evaluation of acute toxicity profile of each participant.

  2 years

• Phase II: Determine Local Control Rate

  To determine the local control rate after the protocol treatment (IG-IMPT or IMRT MTD with simultaneously integrated boost to the high risk margin) followed by surgical resection.

  2 years

Secondary Outcomes (4)

• Overall Survival

  2 years

• Pathologic Response

  2 years

• Tumor Response

  2 years

• Progression-Free Survival Times

  2 years

Study Arms (2)

Treatment Arm IMPT

EXPERIMENTAL

IG-IMPT with SIB to the high risk margin

Radiation: IG-IMPT

Treatment Arm IMRT

EXPERIMENTAL

IG IMRT with SIB to the high risk margin

Radiation: IG IMRT

Interventions

IG-IMPT RADIATION

Daily, Monday-Friday for about 6 weeks

Treatment Arm IMPT

IG IMRT RADIATION

Daily, Monday-Friday for about 6 weeks

Treatment Arm IMRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Dana-Farber Cancer Institute: collaborator
• Roswell Park Cancer Institute: collaborator
• National Cancer Institute (NCI): collaborator
• Duke University: collaborator
• Rush University Medical Center: collaborator
• University of Utah: collaborator
• Washington University School of Medicine: collaborator
• Mayo Clinic: collaborator

Study Sites (10)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55902, United States

RECRUITING

Washington University School of Medicine Siteman Cancer Center West County

Creve Coeur, Missouri, 63141, United States

RECRUITING

Washington University School of Medicine Siteman Cancer Center South County

St Louis, Missouri, 63129, United States

RECRUITING

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

RECRUITING

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Chondrosarcoma, Extraskeletal Myxoid

Study Officials

• Thomas F. DeLaney, M.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas DeLaney, MD

CONTACT

617-726-6876; tdelaney@partners.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Study Record Dates

• First Submitted: August 3, 2012
• First Posted: August 7, 2012
• Study Start: December 1, 2012
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

US (10)