Phase 2 Clinical Trial of Radiomic Habitat-Directed Radiation Dose Escalation for High-Grade Soft Tissue Sarcoma

H. Lee Moffitt Cancer Center and Research Institute1 site in 1 country43 target enrollmentMay 18, 2022

ConditionsHigh Grade Sarcoma

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: High Grade Sarcoma
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Enrollment: 43
Locations: 1
Primary Endpoint: Rate of Favorable Pathologic Response (FPR)
Status: Recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 18, 2022

End Date

August 1, 2026

Last Updated

4 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Responsible Party

Sponsor

Eligibility Criteria

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.

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.

Outcomes

Primary Outcomes

Rate of Favorable Pathologic Response (FPR)

Time Frame: 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.