An Evaluation of PET/CT Imaging as a Predictor of Disease Free Survival Following Neo-Adjuvant Chemotherapy for Soft Tissue Sarcoma
OBJECTIVES:
Primary
- Determine whether measurements of fludeoxyglucose (FDG) positron emission tomography
(PET)/CT imaging can accurately predict disease-free survival of patients with soft
tissue sarcoma who are receiving neoadjuvant chemotherapy.
Secondary
- Correlate histological response to neoadjuvant chemotherapy for soft tissue sarcomas
with FDG-PET/CT imaging findings.
Tertiary
- Determine the changes in FDG-PET/CT imaging over time as each course of chemotherapy is
given.
OUTLINE: Patients receive 1 of 2 standard chemotherapy regimens:
- Preferred regimen: Patients receive pegylated doxorubicin HCl liposome IV on day 1,
ifosfamide IV continuously on days 1-6, and pegfilgrastim subcutaneously (SC) on day 8.
Treatment repeats every 28 days for up to 4 courses in the absence of disease
progression or unacceptable toxicity.
- Alternative regimen: Patients receive doxorubicin hydrochloride IV continuously on days
1-7. Patients also receive ifosfamide and pegfilgrastim as in the preferred regimen.
Treatment repeats every 28 days for up to 4 courses in the absence of disease
progression or unacceptable toxicity.
All patients undergo a fludeoxyglucose positron emission tomography/CT scan at baseline,
after course 1, and after completion of chemotherapy. Patients undergo surgery within 4-6
weeks after completion of chemotherapy.
After completion of study treatment and surgery, patients are followed every 6 months for 5
years.
PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study.
Interventional
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Disease-free survival
Compare changes in baseline and follow-up fludeoxyglucose (FDG) positron emission tomography (PET)/CT imaging with disease-free survival by peak SUV and max SUV calculations. Changes in baseline and follow-up PET/CT, based on max SUV calculations, will be compared with disease free survival. Disease free survival will be measured in months from the time of study enrollment until the time that disease recurrence/relapse/progression is recorded.
Baseline through Survival Event
No
Edward Cheng, MD
Principal Investigator
Masonic Cancer Center, University of Minnesota
United States: Institutional Review Board
2005LS080
NCT00346125
April 2006
April 2014
Name | Location |
---|---|
Sinai Hospital of Baltimore | Baltimore, Maryland 21225 |
Masonic Cancer Center at University of Minnesota | Minneapolis, Minnesota 55455 |