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Proton or Photon RT for Retroperitoneal Sarcomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01659203
Recruitment Status : Recruiting
First Posted : August 7, 2012
Last Update Posted : December 11, 2019
Sponsor:
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):
Tom DeLaney, MD, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE August 3, 2012
First Posted Date  ICMJE August 7, 2012
Last Update Posted Date December 11, 2019
Study Start Date  ICMJE December 2012
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2014)
  • Phase I: Determine MTD [ Time Frame: 2 years ]
    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 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 3, 2012)
  • Phase I: Determine MTD [ Time Frame: 2 years ]
    To determine the maximum tolerated dose (MTD) of preoperative IG-IMPT with 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 ]
    To determine the local control rate after the protocol treatment (IG-IMPT MTD with simultaneously integrated boost to the high risk margin) followed by surgical resection.
Change History Complete list of historical versions of study NCT01659203 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2012)
  • Overall Survival [ Time Frame: 2 years ]
    To estimate overall survival
  • Pathologic Response [ Time Frame: 2 years ]
    To estimate pathologic response (percentage of necrosis and margin status, especially status of the high-risk margin)
  • Tumor Response [ Time Frame: 2 years ]
    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 ]
    To assess progression-free survival times relative to surrogate biological endpoints in tissue and blood in each participant
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Proton or Photon RT for Retroperitoneal Sarcomas
Official Title  ICMJE 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
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Retroperitoneal Sarcoma
Intervention  ICMJE
  • Radiation: IG-IMPT
    Daily, Monday-Friday for about 6 weeks
  • Radiation: IG IMRT
    Daily, Monday-Friday for about 6 weeks
Study Arms  ICMJE
  • Experimental: Treatment Arm IMPT
    IG-IMPT with SIB to the high risk margin
    Intervention: Radiation: IG-IMPT
  • Experimental: Treatment Arm IMRT
    IG IMRT with SIB to the high risk margin
    Intervention: Radiation: IG IMRT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 8, 2014)
80
Original Estimated Enrollment  ICMJE
 (submitted: August 3, 2012)
40
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Thomas DeLaney, MD 617-726-6876 tdelaney@partners.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01659203
Other Study ID Numbers  ICMJE 12-100
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tom DeLaney, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE
  • 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
Investigators  ICMJE
Principal Investigator: Thomas F. DeLaney, M.D. Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP