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Completed

NCT Number: NCT00093509

MRI Sarcoma Non Invasive Thermometry

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.

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Key information

Conditions

Sarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Duke Cancer Institute

Durham, North Carolina, 27710, United States

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doxorubicin hydrochloride

Drug

To be dosed at 75 mg/m2 i.v. push every 4 weeks for 4 cycles. This treatment is optional and will not be used on all subjects.

Other names: Adriamycin

ifosfamide and mesna

Drug

2 gm / m2 ifosfamide mixed in 1000 cc D5W infused continuously over 24 hours daily for 6 days (144 hours); total ifosfamide dose 12 gm/ m2. For the day infusion only MESNA (sodium 2-mercapto-ethanesulphonate) is mixed with ifosfamide as above and given at 2.5 gm / m2 / 24 hours.

Other names: Ifosfamide - Ifex, Mesna - sodium 2-mercapto-ethanesulphonate

hyperthermia treatment with an MRI Compatible Radiofrequency Extremity Hyperthermia Applicator

Procedure

Patients will receive hyperthermia throughout the course of radiotherapy delivered once weekly for a total of 5 treatments. Each treatment will last 1-2 hours with a goal of delivering a cumulative thermal dose of 10-100 CEM 43˚T90.

radiation therapy

Radiation

External beam megavoltage (≥ 4 MV) beams will be used at SSD, SAD ≥ 70 cm at a dose rate of > 100 cGy/min. Fraction sizes of 180 cGy will be used 5 times per weeks in a continuous course. Total dose will be 45 Gy + 10%, consistent with sites being treated.

Primary outcomes

  1. Temperature Rise from Baseline

    Time frame: 1 hour

    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;

Secondary outcomes

  1. Overall Survival

    Time frame: every 6 months for up to 5 years

Sponsors and collaborators

Lead sponsor

Mark Dewhirst

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
1999
Primary completion
2007
Study completion
2009
First posted
Oct 8, 2004
Registry last updated
Sep 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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