Hyperthermia, Radiation Therapy, Surgery, and Optional Chemotherapy in Treating Patients With Soft Tissue Sarcoma of the Limbs
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | November 1999 |
Magnetic Resonance Based Non-Invasive Thermometry for Hyperthermic Treatment of Extremity Soft Tissue Sarcomas: A Multimodal Phase I/II Study
RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above
body temperature. Using MRI to measure heat may help to determine the effectiveness of
hyperthermia therapy. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs
used in chemotherapy, such as ifosfamide and doxorubicin, work in different ways to stop
tumor cells from dividing so they stop growing or die. Combining hyperthermia with radiation
therapy and chemotherapy before surgery may kill more tumor cells and shrink the tumor so
that it can be removed.
PURPOSE: This phase I/II trial is studying the side effects of hyperthermia when given
together with radiation therapy and optional chemotherapy and to see how well they work in
treating patients who are undergoing surgery for soft tissue sarcoma of the limbs.
OBJECTIVES:
Primary
- Determine the feasability 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.
DISEASE CHARACTERISTICS:
- Histologically confirmed grade 2 or 3 soft tissue sarcoma
- No specific tumor size limitation, but the involved extremity must fit within
the hyperthermia applicator
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 70-100%
Life expectancy
- At least 6 months
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Cardiovascular
- Cardiac function ≥ 45% at rest by MUGA
- No cardiac pacemakers or implanted defibrillators that are not treatable by
ultrasound or microwave technology
Other
- No implanted metal (e.g. orthopedic rods, surgical clips, bullets or shrapnel)
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
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