Proton or Photon RT for Retroperitoneal Sarcomas

Status: Recruiting
Phase: Phase 1/Phase 2
Diagnosis: Sarcoma
NCT ID: NCT01659203 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-100

 

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.

 

Conducting Institutions:
Massachusetts General Hospital, Dana-Farber Cancer Institute

Overall PI:
Thomas DeLaney, MD, Massachusetts General Hospital

Site-responsible Investigators:
Elizabeth Baldini, MD, Dana-Farber Cancer Institute

Contacts:
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Leah Killion, RN, 617-525-7385, leah_killion@dfci.harvard.edu
Dana-Farber Cancer Institute: Beverly Spicer, 617-632-5264, bspicer@partners.org

Eligibility 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
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