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Recruiting Phase 2 NCT05301283

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

Trial Parameters

Condition High Grade Sarcoma
Sponsor H. Lee Moffitt Cancer Center and Research Institute
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 43
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-05-18
Completion 2026-08
Interventions
Intensity Modulated Radiation Therapy (IMRT)MRI

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * 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

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