PET CT as Predictor of Response in Preoperative Chemotherapy for Soft Tissue Sarcoma

NACompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

April 10, 2006

Primary Completion Date

July 1, 2013

Study Completion Date

July 31, 2022

Conditions
Sarcoma
Interventions
BIOLOGICAL

pegfilgrastim

will be given at 6 mg subcutaneously (SC) at the end of the mesna infusion

DRUG

doxorubicin hydrochloride

65 mg/m\^2 by continuous intravenous (IV) infusion over 7 days beginning on day 1

DRUG

ifosfamide

9 g/m\^2 by continuous intravenous (IV) infusion over 6 days beginning on day 1 with mesna 10.5 g/m\^2 by continuous IV infusion over 7 days beginning on day 1

DRUG

pegylated liposomal doxorubicin hydrochloride

45 mg/m2 intravenous (IV) Day 1, repeat every 28 days.

PROCEDURE

conventional surgery

The surgical procedure will be decided by the treating physician and independent of study participation

RADIATION

fludeoxyglucose F 18

FDG is a radioactive sugar equal to a uniform whole-body exposure of approximately 1.5 rem for each scan. Post-operative radiation therapy may be given according to institutional guidelines in patients felt to have close surgical margins.

Trial Locations (2)

21215

Sinai Hospital of Baltimore, Baltimore

55455

Masonic Cancer Center at University of Minnesota, Minneapolis

All Listed Sponsors
lead

Masonic Cancer Center, University of Minnesota

OTHER

NCT00346125 - PET CT as Predictor of Response in Preoperative Chemotherapy for Soft Tissue Sarcoma | Biotech Hunter | Biotech Hunter