NCT00346125

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

An Evaluation of PET/CT Imaging as a Predictor of Disease Free Survival Following Neo-Adjuvant Chemotherapy for Soft Tissue Sarcoma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) scan and computated tomography (CT) scan, may help doctors predict a patient's response to treatment and may help plan the best treatment. Drugs used in chemotherapy, such as doxorubicin and ifosfamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This clinical trial is studying how well PET scan combined with CT scan predicts response in patients undergoing chemotherapy and surgery for soft tissue sarcoma.

Detailed description

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.

Conditions

• Sarcoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-04-10
• Primary completion: 2013-07-01
• Completion: 2022-07-01
• First posted: 2006-06-29
• Last updated: 2022-12-15

Locations

2 sites across 1 country: United States