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Magnetic Resonance Based Non-Invasive Thermometry for Hyperthermic Treatment of Extremity Soft Tissue Sarcomas: A Multimodal Phase I/II Study


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Sarcoma

Thank you

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