Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
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
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