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  • Cancer Type: Sarcoma
  • Study Type: Treatment
  • NCT#: NCT05301283
  • Phase: Phase II
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  • Overview

    Study Title:

    Phase 2 Clinical Trial of Radiomic Habitat-Directed Radiation Dose Escalation for High-Grade Soft Tissue Sarcoma

    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.

    Objective:

    Primary Objective: Utilizing radiomic habitats to focally dose escalate radioresistant subregions of high-grade soft tissue sarcoma to improve the rate of favorable pathologic response (Favorable pathologic response [FPR]: tumor necrosis >/= 95%) at the time of surgery. Secondary Objectives: To estimate the rates of acute toxicity (defined by CTCAE v5.0 within 120 days) for patients with high-grade soft tissue sarcoma treated with preoperative habitat-directed dose escalation To estimate R0 resection rate To evaluate early treatment response to radiation on imaging To evaluate pathologic response to radiation of each habitat

  • Treatments

    Therapies:

    Radiotherapy

    Medications:

    Radiotherapy ()

  • Inclusion 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.
    • Other criteria may apply
  • Exclusion Criteria

      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.
    • Other exclusions may apply

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