NCT05301283 Habitat Escalated Adaptive Therapy (HEAT), With Neoadjuvant Radiation for Soft Tissue Sarcoma
| NCT ID | NCT05301283 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | H. Lee Moffitt Cancer Center and Research Institute |
| Condition | High Grade Sarcoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 43 participants |
| Start Date | 2022-05-18 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 43 participants in total. It began in 2022-05-18 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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. Exclusion Criteria: * 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.
Contact & Investigator
Arash O Naghavi, MD, MS
PRINCIPAL INVESTIGATOR
Moffitt Cancer Center
Frequently Asked Questions
Who can join the NCT05301283 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying High Grade Sarcoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05301283 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05301283 currently recruiting?
Yes, NCT05301283 is actively recruiting participants. Contact the research team at Inaya.Lemus@moffitt.org for enrollment information.
Where is the NCT05301283 trial being conducted?
This trial is being conducted at Tampa, United States.
Who is sponsoring the NCT05301283 clinical trial?
NCT05301283 is sponsored by H. Lee Moffitt Cancer Center and Research Institute. The principal investigator is Arash O Naghavi, MD, MS at Moffitt Cancer Center. The trial plans to enroll 43 participants.