Proton or Photon RT for Retroperitoneal Sarcomas

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically proven primary soft tissue sarcoma of the retroperitoneum

Measurable disease

Life expectancy of greater than 2 years

Disqualifiers

Prior radiation therapy for retroperitoneal sarcoma

Pregnant or breastfeeding

Chemotherapy within 4 weeks prior to entering study

Receiving other investigational agents

Trial design

Design model

Parallel

Treatments tested in this trial

  • IG-IMPT

    Radiation

    Daily, Monday-Friday for about 6 weeks

  • IG IMRT

    Radiation

    Daily, Monday-Friday for about 6 weeks

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Treatment Arm IMPTExperimental treatment 1 intervention
Group B: Treatment Arm IMRTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
2 years
2

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.

Time frame
2 years

Secondary outcomes

1

Overall Survival

To estimate overall survival

Time frame
2 years
2

Pathologic Response

To estimate pathologic response (percentage of necrosis and margin status, especially status of the high-risk margin)

Time frame
2 years
3

Tumor Response

To estimate the tumor response through the comparison of CT imaging before and after the protocol treatment.

Time frame
2 years
4

Progression-Free Survival Times

To assess progression-free survival times relative to surrogate biological endpoints in tissue and blood in each participant

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

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