MRI Sarcoma Non Invasive Thermometry

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

November 30, 1999

Primary Completion Date

July 31, 2007

Study Completion Date

October 31, 2009

Conditions
Sarcoma
Interventions
DRUG

doxorubicin hydrochloride

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.

DRUG

ifosfamide and mesna

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.

PROCEDURE

hyperthermia treatment with an MRI Compatible Radiofrequency Extremity Hyperthermia Applicator

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

radiation therapy

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.

Trial Locations (1)

27710

Duke Cancer Institute, Durham

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Mark Dewhirst

OTHER