Magnetic Resonance Based Non-Invasive Thermometry for Hyperthermic Treatment of Extremity Soft Tissue Sarcomas: A Multimodal Phase I/II Study
- Determine the feasibility and accuracy of real time magnetic resonance-based
non-invasive thermometry in patients with grade 2 or 3 soft tissue sarcoma of the
extremity receiving combination hyperthermia, radiotherapy, surgery, and optional
high-dose ifosfamide and doxorubicin.
- Determine the local control, disease-free survival, and overall survival of patients
treated with this regimen.
- Determine acute and late toxic effects of this regimen in these patients.
- Correlate measurements of tumor physiology, defined by gadolinium-enhanced magnetic
resonance imaging, magnetic resonance spectroscopy, and tumor oxygenation, with
clinical and/or pathological response and/or metastatic potential in patients treated
with this regimen.
OUTLINE: Patients may receive high-dose ifosfamide IV continuously over 6 days (144 hours).
Beginning 3 weeks after the completion of ifosfamide, patients undergo radiotherapy once
daily, 5 days a week, for 5 weeks. Beginning 1 hour after radiotherapy, patients also
undergo hyperthermia (with heat measured by conventional and magnetic resonance-based
thermometry) over 1-2 hours once weekly for 5 weeks. Approximately 4 weeks after the
completion of radiotherapy and hyperthermia, patients undergo surgery. Approximately 1 month
after surgery, patients may then receive high-dose doxorubicin IV once every 4 weeks for 4
PROJECTED ACCRUAL: A total of 10-30 patients will be accrued for this study within 2-6
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Temperature Rise from Baseline
MR-based thermometry measures: We are assessing agreement between the non-invasive MR measurements versus the invasive interstitial point measurements. The equivalence of median temperature measured within one or more MR ROI's (regions-of-interest in the MR image) and temperatures measured invasively in tissue immediately adjacent to those ROI's;
Ellen L. Jones, MD, PhD
Duke Cancer Institute
United States: Food and Drug Administration
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