NCT05301283 · H. Lee Moffitt Cancer Center and Research Institute
Habitat Escalated Adaptive Therapy (HEAT), With Neoadjuvant Radiation for Soft Tissue Sarcoma
What this study is about
The purpose of the study is to utilize radiomic images to precisely locate areas of tumor that can be treated with gradually increasing doses radiation therapy.
View original scientific description
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
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Tampa, Florida
Collaborators
Viewray Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 4, 2025 · Source of record for eligibility and locations