Habitat Escalated Adaptive Therapy (HEAT), With Neoadjuvant Radiation for Soft Tissue Sarcoma
Part of paid clinical trials in Tampa, Florida.
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Study ID
- NCT05301283
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- High Grade Sarcoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Intensity Modulated Radiation Therapy (IMRT) — RADIATIONParticipants will be treated with intensity modulated radiation therapy (IMRT) with photons, which is FDA (U.S. Food and Drug Administration) approved radiation delivery system.
- MRI — DIAGNOSTIC_TESTParticipants will receive pretreatment diagnostic MRIs to generate MRI habitats. These images will identify radioresistant cells within tumor.
Study Details
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.
Key Dates
- Start date
- May 18, 2022
- Status verified
- Dec 2025
- Primary completion
- Aug 31, 2026
- Completion
- Aug 31, 2026
Study Design
- Enrollment
- 43 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: TreatmentParticipants will receive pretreatment diagnostic MRIs to generate MRI habitats (images of tumor regions/subregions in different sequences). These images will identify radioresistant cells within the tumor to allow for more precise and higher doses of radiation to the resistant cells. Participants will then be treated with neoadjuvant external beam radiation by using the intensity modulated radiation (IMRT) technique, with dose painting (simultaneous integrated boost/SIB) to 70 Gray Units (Gy), 60 Gy, and 50 Gy in 25 fractions for habitats 1, 2, and 3, respectively.
Primary Outcome Measure
Rate of Favorable Pathologic Response (FPR) [ Time Frame: Week 10 ]
Central Contacts
- Inaya Lemus813-745-4233
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | Arash O Naghavi, MD, MS (PRINCIPAL_INVESTIGATOR) Marilyn Bui, MD, PhD (SUB_INVESTIGATOR) Ricardo Gonzalez, PhD (SUB_INVESTIGATOR) Nainesh Parikh, MD, MBA (SUB_INVESTIGATOR) |
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