Study on Habitat Escalated Adaptive Therapy (HEAT) with Pre-Surgery Radiation for Soft Tissue Sarcoma

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05301283

This clinical trial is exploring a new method using advanced imaging to target and treat specific areas of soft tissue sarcoma with higher doses of radiation before surgery.

Patient Parameters

Program Overview

The aim of this study is to use special imaging techniques to identify and precisely target areas of soft tissue sarcoma tumors for increased radiation treatment before surgery. This approach is intended to improve the effectiveness of the treatment by focusing on the most critical parts of the tumor.

Eligibility Criteria

Inclusion Criteria

  • Must provide signed and dated consent to participate in the study.
  • Willingness to follow all study procedures and be available for the entire study duration.
  • Women who can become pregnant must use highly effective birth control for at least one month before the study and continue for 52 weeks after radiation treatment.
  • Men who can father children must use condoms or other effective birth control methods with their partners for 52 weeks after radiation treatment.
  • Agree to follow lifestyle guidelines as outlined in the study protocol.
  • Must have a confirmed diagnosis of high-grade (grade 2 or 3) Soft Tissue Sarcoma (STS) located deep in the trunk or limbs.
  • The primary tumor site must be considered removable by surgery before starting the trial.
  • Cancer staging must be T1-4 N0 M0, meaning no distant spread of the cancer.
  • Must have measurable disease at the primary tumor site, confirmed by clinical or imaging evidence.
  • Must have an MRI scan within 4 weeks before starting radiation therapy.
  • Must have an ECOG Performance Status score between 0 and 3, indicating varying levels of activity.
  • Must be considered a candidate for surgery.
  • Must agree to have blood and plasma samples preserved for future research.

Exclusion Criteria

  • Cannot undergo an MRI scan.
  • Positive pregnancy test.
  • Complete removal of the primary tumor, including any unplanned removal.
  • Superficial sarcoma located mainly in the skin or just below the skin.
  • Previous radiation treatment to the same area that would overlap with the study's radiation fields.
  • Any medical condition or social situation that, in the opinion of the study leader, would prevent completion of the trial.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.