Using advanced radiation therapy for high-grade soft tissue sarcoma treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Fluorescence-guided surgery to reduce unexpected positive margins in high-grade sarcoma

  This phase II trial tests whether adding fluorescence-guided surgery with indocyanine green can lower unexpected positive margins in patients with high-grade sarcoma compared to standard surgery.

  Recruiting Phase 2 City of Hope Medical Center · Duarte, California · NCT07650656

• Melanoma treatment with immunotherapy guided by serial ctDNA testing

  This trial tests whether regular ctDNA blood tests during treatment can help tailor the plan for patients with advanced melanoma receiving nivolumab and ipilimumab.

  Recruiting Phase 2 H. Lee Moffitt Cancer Center and Research Institute · Tampa, Florida · NCT07930182

• Domatinostat with Sirolimus for relapsed or refractory sarcoma and osteosarcoma

  This study tests whether the cancer drugs domatinostat and sirolimus together can help adolescents and adults whose sarcoma or osteosarcoma has come back or stopped responding to standard therapy.

  Recruiting at 2 sites Phase 1/2 H. Lee Moffitt Cancer Center and Research Institute · Tampa, Florida and 3 other locations · NCT07725380

• Dendritic Cell Vaccine with HER2-targeted Therapy or Nivolumab for Breast Cancer with Leptomeningeal Metastasis

  This trial tests a dendritic cell vaccine added to trastuzumab for Her2-positive disease or to nivolumab for Her2-negative disease to see if it can be given safely to people with breast cancer that has spread to the leptomeninges.

  Recruiting Phase 2 H. Lee Moffitt Cancer Center and Research Institute · Tampa, Florida · NCT07694986

• See if SAVI Scout MD helps surgeons localize breast cancer more precisely

  This study tests whether the SAVI Scout MD radar reflectors help surgeons find and remove breast cancer more accurately, potentially reducing the need for a second operation.

  Recruiting Phase 2 H. Lee Moffitt Cancer Center and Research Institute · Tampa, Florida · NCT07686250

• PIPAC with Mitomycin C for unresectable peritoneal cancer

  This phase 1 study tests a breathy, pressurized chemotherapy method (PIPAC-MMC) to see if it is safe and tolerable for adults with unresectable peritoneal carcinomatosis from colorectal, appendiceal, or small bowel cancers.

  Recruiting Phase 1 H. Lee Moffitt Cancer Center and Research Institute · Tampa, Florida · NCT07487168

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.