Habitat Escalated Adaptive Therapy (HEAT), With Neoadjuvant Radiation for Soft Tissue Sarcoma

Phase 2

Recruiting

• Conditions: High Grade Sarcoma

• Registration Number: NCT05301283
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

The purpose of the study is to utilize radiomic images to precisely locate areas of tumor that can be treated with dose escalation radiation therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-18
• Study First Submitted QC: 2022-03-18
• Study First Posted: 2022-03-29
• Study Start: 2022-05-18
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-06
• Primary Completion: 2025-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• For women of childbearing potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 52 weeks after the end of radiation.
• For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner 52 weeks after radiation.
• Agreement to adhere to Lifestyle Considerations (as outlined in protocol) throughout study duration.
• Pathologically (histologically or cytologically) proven diagnosis of high-grade (grade 2 or 3) Soft Tissue Sarcoma (STS) of the deep trunk and/or extremity. Clinical evidence should be documented, and may consist of pathology or imaging, and should be sufficient to estimate the size of the primary (for T stage)
• Primary site deemed resectable prior to the start of trial
• American Joint Committee on Cancer (AJCC) 8th edition staging T1-4 N0 M0, no evidence of distant metastases
• Patients must have clinically or radiographically evident measurable disease at the primary site.
• Pre-Radiation Therapy (RT) MRI within 4 weeks of the start of RT.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 3.
• Deemed a surgical candidate
• Participant agrees to blood and plasma preservation for future analysis.

Exclusion Criteria

• Contraindications to an MRI
• Positive urine pregnancy test
• Gross total excision of primary STS, including an unplanned excision
• Superficial sarcoma located primarily in the subcutaneous or cutaneous tissue
• Prior radiation to the region of the study cancer that would result in overlap of radiation therapy fields.
• Participants with a medical condition or social situation that, at the discretion of the principal investigator, would preclude them from completion of the trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Rate of Favorable Pathologic Response (FPR)	Week 10	Percentage of participants with Favorable Pathologic Response (FPR): tumor necrosis \>/= 95% at time of surgery. FPR is associated with improved R0 resection rates, local control, distant control, and overall survival. Therefore, FPR acts as an early surrogate for outcome.

Secondary Outcome Measures

Name	Time	Method
Percentage of tumor with clear margin and positive margin	Weeks 10-13	Review of final tumor margin of the surgical specimen, defined as tumor at ink margin, will be conducted by pathologist. A clear margin (R0) or a positive margin (R1/R2) will be designated, along with the location of the margin, which will be radiographically correlated to the habitat . Surgical margins are independent predictors for local control.

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States