Preoperative Proton or Photon (IMRT) Radiation

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.

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.

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.

Live record on ClinicalTrials.gov →

• Histologically proven primary soft tissue sarcoma of the retroperitoneum
• Life expectancy of greater than 2 years

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.