Study on Proton-Spatially Fractionated Radiotherapy and Standard Radiation Therapy for Newly Diagnosed Retroperitoneal Soft Tissue Sarcoma

Sponsor: Northwestern University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06327477

Provider View

This clinical trial is exploring a new radiation treatment method called proton-spatially fractionated radiotherapy (P-SFRT) combined with standard radiation therapy to treat patients with newly diagnosed retroperitoneal soft tissue sarcoma. The study aims to find the best dose and assess how well this combination works in shrinking tumors.

Patient Parameters

Program Overview

This study is testing a new way to deliver radiation therapy called proton-spatially fractionated radiotherapy (P-SFRT) along with standard radiation therapy for patients with newly diagnosed retroperitoneal soft tissue sarcoma. Radiation therapy uses high-energy rays to kill cancer cells and shrink tumors. P-SFRT involves delivering different doses of radiation to different parts of the tumor, which may help in killing cancer cells more effectively. Proton therapy, a type of radiation therapy, can target tumors more precisely, allowing higher doses to the tumor while sparing nearby healthy tissues. This study aims to see if combining P-SFRT with standard radiation therapy is more effective in treating this type of cancer.

Description

The study is divided into two phases: Phase I and Phase II.

In Phase I, the goal is to find the highest dose of P-SFRT that patients can tolerate without severe side effects. This dose will be used in Phase II to test how well the treatment works.

In Phase II, researchers will evaluate the effectiveness of P-SFRT in combination with standard radiation therapy and surgery in treating retroperitoneal soft tissue sarcoma. They will look at how long patients live without the cancer getting worse and overall survival rates.

Participants will receive P-SFRT followed by image-guided intensity modulated radiation therapy (IG-IMRT) over several weeks. After completing radiation therapy, patients will undergo surgery to remove the tumor. Blood samples and biopsies will be collected during the study, and patients will have follow-up visits to monitor their health and the treatment's effects.

The study aims to provide insights into whether this new combination of radiation therapies can improve outcomes for patients with this type of cancer.

Eligibility Criteria

Inclusion Criteria

  • Must have a newly diagnosed retroperitoneal soft tissue sarcoma confirmed by lab tests.
  • The tumor must be at least 3 cm in size.
  • Must have measurable disease according to specific medical criteria.
  • Must be 18 years or older.
  • Must be in good overall health with a performance status score of 0 or 1.
  • Must have adequate blood cell counts and organ function as determined by specific blood tests.
  • Must agree to use effective contraception during the study and for a specified period after treatment.
  • Must be able to understand and sign a written informed consent document.
  • Must be medically fit for surgery and plan to undergo radiation therapy and surgery with the intent to cure the cancer.

Exclusion Criteria

  • Have certain types of soft tissue sarcoma where chemotherapy is the standard treatment.
  • Have had prior radiation therapy to the affected area.
  • Have received chemotherapy or other cancer treatments within a specified time before the study.
  • Have not recovered from side effects of previous cancer treatments.
  • Have taken steroids or immunosuppressive drugs recently.
  • Have a history of active tuberculosis or hepatitis B or C infections.
  • Have distant metastatic disease, including brain metastases.
  • Have a history of lung inflammation requiring steroids.
  • Have received a live vaccine recently.
  • Have had an organ transplant.
  • Have certain inflammatory or rheumatologic disorders.
  • Have uncontrolled health conditions like high blood pressure or heart problems.
  • Have psychiatric or social issues that would affect study participation.
  • Are pregnant or nursing, or planning to become pregnant or father a child during the study.
  • Are participating in another clinical trial or have used an investigational device recently.

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