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

Official title

Phase 2 Clinical Trial of Radiomic Habitat-Directed Radiation Dose Escalation for High-Grade Soft Tissue Sarcoma

Overview

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.

Interventions

• Radiation Intensity Modulated Radiation Therapy (IMRT)
  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.
• Diagnostic test MRI
  Participants will receive pretreatment diagnostic MRIs to generate MRI habitats. These images will identify radioresistant cells within tumor.

Primary outcome measures

• Rate of Favorable Pathologic Response (FPR) [Time frame: Week 10]

Secondary outcome measures (1)

• Percentage of tumor with clear margin and positive margin [Time frame: Weeks 10-13]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Moffitt Cancer Center — Tampa

Publications

• 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 radiati PMID 38594603

Identifiers

NCT: NCT05301283 · MCC-21136

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗