NCT05301283RecruitingPhase 2
Habitat Escalated Adaptive Therapy (HEAT), With Neoadjuvant Radiation for Soft Tissue Sarcoma
Phase 2 Clinical Trial of Radiomic Habitat-Directed Radiation Dose Escalation for High-Grade Soft Tissue Sarcoma
Source: ClinicalTrials.gov · Last updated 4 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 43 (estimated)
- First submitted
- 18 Mar 2022
- Start date
- May 2022
- Primary completion date
- Aug 2026
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Diseases
- Sarcoma
- NCT number
- NCT05301283
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 43
- From May 2022 to the primary completion date, Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior radiation to the region of the study cancer that would result in overlap of radiation therapy fields.
Other illness
- Participants with a medical condition or social situation that, at the discretion of the principal investigator, would preclude them from completion of the trial.
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.