Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05301283

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

Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2025-12-04

43

Participants Needed

1

Research Sites

219 weeks

Total Duration

On this page

Sponsors

H

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

V

Viewray Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed and dated informed consent form provided
  • Willingness to comply with all study procedures and availability for the study duration
  • Women of childbearing potential must use highly effective contraception starting 1 month before screening and during study participation plus 52 weeks after radiation
  • Males of reproductive potential must use condoms or other effective contraception methods with partner for 52 weeks after radiation
  • Agreement to follow lifestyle considerations throughout the study
  • Pathologically confirmed diagnosis of high-grade (grade 2 or 3) soft tissue sarcoma of the deep trunk and/or extremity
  • Primary tumor site deemed resectable before starting the trial
  • AJCC 8th edition staging T1-4 N0 M0 with no distant metastases
  • Clinically or radiographically measurable disease at the primary site
  • Pre-radiation MRI done within 4 weeks before starting radiation therapy
  • ECOG performance status between 0 and 3
  • Deemed a surgical candidate
  • Agreement to blood and plasma sample preservation for future analysis
Not Eligible

You will not qualify if you...

  • Contraindications to MRI
  • Positive urine pregnancy test
  • Gross total excision of primary soft tissue sarcoma, including unplanned excision
  • Superficial sarcoma mainly located in subcutaneous or cutaneous tissue
  • Prior radiation to the cancer region that would overlap radiation therapy fields
  • Medical or social conditions that would prevent trial completion as determined by the principal investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Moffitt Cancer Center

Tampa, Florida, United States, 33612

Actively Recruiting

Loading map...

Research Team

I

Inaya Lemus

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

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