Proton or Photon RT for Retroperitoneal Sarcomas

Retroperitoneal Sarcoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01659203
• Other study ID #: 12-100
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 2012
• Est. completion date: August 2025

Study information

• Verified date: September 2020
• Source: Massachusetts General Hospital
• Contact: Thomas DeLaney, MD
• Phone: 617-726-6876
• Email: tdelaney[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Retroperitoneal Sarcoma
• Sarcoma

Intervention

Radiation:
• IG-IMPT
Daily, Monday-Friday for about 6 weeks
• IG IMRT
Daily, Monday-Friday for about 6 weeks

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Rush University Medical Center	Chicago	Illinois
United States	Washington University School of Medicine Siteman Cancer Center West County	Creve Coeur	Missouri
United States	Duke University	Durham	North Carolina
United States	MD Anderson Cancer Center	Houston	Texas
United States	Mayo Clinic	Rochester	Minnesota
United States	Washington University School of Medicine Siteman Cancer Center South County	Saint Louis	Missouri
United States	University of Utah	Salt Lake City	Utah

Sponsors (9)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Dana-Farber Cancer Institute, Duke University, Mayo Clinic, National Cancer Institute (NCI), Roswell Park Cancer Institute, Rush University Medical Center, University of Utah, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Overall Survival	To estimate overall survival	2 years
Secondary	Pathologic Response	To estimate pathologic response (percentage of necrosis and margin status, especially status of the high-risk margin)	2 years
Secondary	Tumor Response	To estimate the tumor response through the comparison of CT imaging before and after the protocol treatment.	2 years
Secondary	Progression-Free Survival Times	To assess progression-free survival times relative to surrogate biological endpoints in tissue and blood in each participant	2 years