Proton or Photon RT for Retroperitoneal Sarcomas

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Massachusetts General Hospital
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
University of Pennsylvania
Roswell Park Cancer Institute
Information provided by (Responsible Party):
Tom DeLaney, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01659203
First received: August 3, 2012
Last updated: April 8, 2014
Last verified: April 2014
  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 Intervention Phase
Retroperitoneal Sarcoma
Radiation: IG-IMPT
Radiation: IG IMRT
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Phase I: Determine MTD [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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.

  • Phase II: Determine Local Control Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To estimate overall survival

  • Pathologic Response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To estimate pathologic response (percentage of necrosis and margin status, especially status of the high-risk margin)

  • Tumor Response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To estimate the tumor response through the comparison of CT imaging before and after the protocol treatment.

  • Progression-Free Survival Times [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To assess progression-free survival times relative to surrogate biological endpoints in tissue and blood in each participant


Estimated Enrollment: 80
Study Start Date: December 2012
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
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

Detailed Description:

While being screened to determine eligibility for this study you may choose to participate in an additional blood sample for circulating DNA and a genomic DNA sample.

Since we are looking for the highest dose of Radiation Therapy that can be administered safely without severe or unmanageable side effects in participants that have retroperitoneal sarcomas, not everyone who participates in this research study will receive the same dose of study therapy. The dose you get will depend on the number of participants who have been enrolled in the study before you and how well they have tolerated their doses. Your study doctor will tell you which dose you will get.

Radiation planning is standard of care for all patients undergoing radiation therapy. Before you begin radiation therapy you will have a radiation planning CT scan of the tumor site. This scan will be in addition to the scans done in order to confirm your eligibility for this study. Doctors will use teh images from this scan to plan your radiation treatment.

You will receive radiation therapy every day Monday through Friday for about six weeks. You will receive study therapy as an outpatient. During radiation therapy, you will be seen by the study doctor once a week. Each visit will take about 15 minutes, and the following assessments will be completed: medical history, vital signs, body weight and assessments for any side effects you may be experiencing.

After the final dose of radiation therapy you will be assessed for side effects of radiation following your last dose and before surgery. The following assessments will be completed before your surgery at this visit: Chest CT, CT/MRI of the abdomen/pelvis and routine blood tests to check for overall health.

You will be seen for a follow-up visit within one month of discharge following surgery and again four months after the surgery. At the first follow-up visit, the following assessment will be completed: medical history, vital signs and body weight, questions about side effects and routine blood tests to check for overall health. At the four month follow up visit the following assessment will be completed: medical history, vital signs and body weight, chest CT and abdominal/pelvic CT.

After your four month follow-up visit, you will be seen twice yearly following radiation for the first five years and then once a year for the rest of your life.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Thomas DeLaney, MD 617-726-6876 tdelaney@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Thomas DeLaney, MD    617-726-6876    tdelaney@partners.org   
Principal Investigator: Thomas DeLaney, MD         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Elizabeth Baldini, MD, MPH    617-732-6310    ebaldini@partners.org   
Principal Investigator: Elizabeth Baldini, MD, MPH         
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
University of Pennsylvania
Roswell Park Cancer Institute
Investigators
Principal Investigator: Thomas F. DeLaney, M.D. Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Tom DeLaney, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01659203     History of Changes
Other Study ID Numbers: 12-100
Study First Received: August 3, 2012
Last Updated: April 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
extraskeletal chondrosarcoma

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on July 29, 2014