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

NCT05301283 | Recruiting Phase 2 DMC

• 1 other identifier: MCC-21136
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

High Grade Sarcoma

Outcome Measures

Primary Outcomes (1)

• Rate of Favorable Pathologic Response (FPR)

  Percentage of participants with Favorable Pathologic Response (FPR): tumor necrosis \>/= 95% at time of surgery. FPR is associated with improved R0 resection rates, local control, distant control, and overall survival. Therefore, FPR acts as an early surrogate for outcome.

  Week 10

Secondary Outcomes (1)

• Percentage of tumor with clear margin and positive margin

  Weeks 10-13

Other Outcomes (2)

• Disease Control Rate

  Up to 6 months

• Overall Survival

  Up to 8 months

Study Arms (1)

Treatment

EXPERIMENTAL

Participants 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.

Radiation: Intensity Modulated Radiation Therapy (IMRT); Diagnostic Test: MRI

Interventions

Intensity Modulated Radiation Therapy (IMRT) RADIATION

Participants will be treated with intensity modulated radiation therapy (IMRT) with photons, which is FDA (U.S. Food and Drug Administration) approved radiation delivery system.

Treatment

MRI DIAGNOSTIC_TEST

Participants will receive pretreatment diagnostic MRIs to generate MRI habitats. These images will identify radioresistant cells within tumor.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Viewray Inc.: collaborator

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Related Publications (1)

• Naghavi AO, Bryant JM, Kim Y, Weygand J, Redler G, Sim AJ, Miller J, Coucoules K, Michael LT, Gloria WE, Yang G, Rosenberg SA, Ahmed K, Bui MM, Henderson-Jackson EB, Lee A, Lee CD, Gonzalez RJ, Feygelman V, Eschrich SA, Scott JG, Torres-Roca J, Latifi K, Parikh N, Costello J. Habitat escalated adaptive therapy (HEAT): a phase 2 trial utilizing radiomic habitat-directed and genomic-adjusted radiation dose (GARD) optimization for high-grade soft tissue sarcoma. BMC Cancer. 2024 Apr 9;24(1):437. doi: 10.1186/s12885-024-12151-7.

  PMID: 38594603 DERIVED

Related Links

• Moffitt Cancer Center Clinical Trials website

MeSH Terms

Interventions

Radiotherapy, Intensity-Modulated

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Arash O Naghavi, MD, MS

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Inaya Lemus

CONTACT

813-745-4233; Inaya.Lemus@moffitt.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: March 29, 2022
• Study Start: May 18, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)