Using advanced radiation therapy for high-grade soft tissue sarcoma treatment
Phase 2 Clinical Trial of Radiomic Habitat-Directed Radiation Dose Escalation for High-Grade Soft Tissue Sarcoma
This study is testing a new way of using advanced radiation therapy to treat high-grade soft tissue sarcoma by targeting specific areas of the tumor to improve treatment while protecting healthy tissue.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 43 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | H. Lee Moffitt Cancer Center and Research Institute Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Tampa, Florida) |
| Trial ID | NCT05301283 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the treatment of high-grade soft tissue sarcoma by employing radiomic imaging to identify specific tumor areas that can benefit from dose escalation radiation therapy. Participants will receive intensity-modulated radiation therapy (IMRT) tailored to their tumor characteristics. The approach focuses on improving the precision of radiation delivery to maximize treatment efficacy while minimizing damage to surrounding healthy tissue. The study is designed for patients with confirmed high-grade sarcoma located in the deep trunk or extremities.
Who should consider this trial
Good fit: Ideal candidates are individuals with a confirmed diagnosis of high-grade soft tissue sarcoma of the deep trunk or extremities who can comply with study protocols.
Not a fit: Patients with low-grade sarcomas or those unable to adhere to study protocols may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective treatment options for patients with high-grade soft tissue sarcoma.
How similar studies have performed: Other studies utilizing advanced imaging techniques for targeted radiation therapy have shown promising results, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tampa, Florida
- Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Arash O Naghavi, MD, MS — Moffitt Cancer Center
- Study coordinator: Inaya Lemus
- Email: Inaya.Lemus@moffitt.org
- Phone: 813-745-4233
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.