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

Recruiting now · Phase 2

Conditions studied: High Grade Sarcoma

In brief

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 facts

Study ID

NCT05301283

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

43

Starts

2022-05-18

Expected to finish

2026-08-01

Last updated by the study team

2025-12-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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