Magnetic Resonance Based Non-Invasive Thermometry for Hyperthermic Treatment of Extremity Soft Tissue Sarcomas: A Multimodal Phase I/II Study
18 Years
N/A
Both
Sarcoma
Trial Information
Magnetic Resonance Based Non-Invasive Thermometry for Hyperthermic Treatment of Extremity Soft Tissue Sarcomas: A Multimodal Phase I/II Study
OBJECTIVES:
Primary
- 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.
Secondary
- 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
courses.
PROJECTED ACCRUAL: A total of 10-30 patients will be accrued for this study within 2-6
years.
Inclusion Criteria:
- Patients will have histologically proven grade 2 or grade 3 soft tissue sarcoma.
- Karnofsky performance status ≥ 70.
- Life expectancy ≥ 6 months.
- There is no specific tumor size limitation, but the involved extremity must fit
within the hyperthermia applicator.
- Patients must be ≥ 18 years of age.
- Patients who are to receive chemotherapy must have a left ventricular ejection
fraction on resting MUGA scan of at least 45% to confirm adequate cardiac function
- Patients must competent to consent to be in the study and sign an approved informed
consent.
Exclusion Criteria:
- Pregnant patients
- Patients with cardiac pacemakers and implanted defibrillators or other devices not
compatible with ultrasound or microwave technology
- Patients who have any metal in their bodies including orthopedic rods, surgical
clips, bullets, or shrapnel, etc. unless cleared by MRI staff and Hyperthermia
physicians
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Temperature Rise from Baseline
Outcome Description:
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;
Outcome Time Frame:
1 hour
Safety Issue:
No
Principal Investigator
Ellen L. Jones, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Duke Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
Pro00008831
NCT ID:
NCT00093509
Start Date:
November 1999
Completion Date:
October 2009
Related Keywords:
- Sarcoma
- stage I adult soft tissue sarcoma
- stage II adult soft tissue sarcoma
- stage III adult soft tissue sarcoma
- stage IV adult soft tissue sarcoma
- Sarcoma
Name | Location |
|---|---|
| Duke Cancer Institute | Durham, North Carolina 27710 |
