Clinical trial NCT05301283: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: High Grade Sarcoma
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Viewray Inc.
First posted: 2022-03-29
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Rate of Favorable Pathologic Response (FPR)
timeFrame: Week 10
Secondary outcomes:
measure: Percentage of tumor with clear margin and positive margin
timeFrame: Weeks 10-13
Other outcomes:
measure: Disease Control Rate
timeFrame: Up to 6 months
measure: Overall Survival
timeFrame: Up to 8 months
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Arash O Naghavi, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: