High Grade SarcomaPhase 2NCT05301283
Habitat Escalated Adaptive Therapy (HEAT), With Neoadjuvant Radiation for Soft Tissue Sarcoma
A Phase 2 study testing Intensity Modulated Radiation Therapy (IMRT) and MRI in people with High Grade Sarcoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Grade Sarcoma
- What is being tested?
- Intensity Modulated Radiation Therapy (IMRT) and MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2022to Aug 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Arash O Naghavi, MD, MS
Marilyn Bui, MD, PhD
About this study
Official title: Phase 2 Clinical Trial of Radiomic Habitat-Directed Radiation Dose Escalation for High-Grade Soft Tissue Sarcoma
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
- Being tested
- Intensity Modulated Radiation Therapy (IMRT), MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
MRIDiagnostic test
Participants will receive pretreatment diagnostic MRIs to generate MRI habitats. These images will identify radioresistant cells within tumor.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Intensity Modulated Radiation Therapy (IMRT); Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 10
Secondary outcomes (1)
Percentage of tumor with clear margin and positive margin
Review of final tumor margin of the surgical specimen, defined as tumor at ink margin, will be conducted by pathologist. A clear margin (R0) or a positive margin (R1/R2) will be designated, along with the location of the margin, which will be radiographically correlated to the habitat . Surgical margins are independent predictors for local control.
Measured: Weeks 10-13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start18 May 2022
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High Grade SarcomaStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Viewray Inc.
- Responsible party
- Sponsor
- Investigators
- Arash O Naghavi, MD, MS, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301283
- Sponsor's protocol ID
- MCC-21136
- Status last verified
- Dec 2025
- First submitted
- 18 Mar 2022
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 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.
PubMed 38594603
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Clinical Trial of Radiomic Habitat-Directed Radiation Dose Escalation for High-Grade Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT05301283
- Acronym / sponsor ID
- MCC-21136
- Conditions
- High Grade Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Viewray Inc.
- Study start
- 18 May 2022 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Radiation: Intensity Modulated Radiation Therapy (IMRT), Diagnostic Test: MRIParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Radiation | Treatment |
| MRIParticipants will receive pretreatment diagnostic MRIs to generate MRI habitats. These images will identify radioresistant cells within tumor. | Diagnostic test | Treatment |
Primary outcome
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.
1 secondary outcome
Percentage of tumor with clear margin and positive margin
Time frame: Weeks 10-13
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Derived from this study: PubMed 38594603Naghavi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arash O Naghavi, MD, MS principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intensity Modulated Radiation Therapy (IMRT) and MRI in people with High Grade Sarcoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Inaya Lemus (813-745-4233, Inaya.Lemus@moffitt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Favorable Pathologic Response (FPR) (time frame: Week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05301283, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.