An Evaluation of PET/CT Imaging as a Predictor of Disease Free Survival Following Neo-Adjuvant Chemotherapy for Soft Tissue Sarcoma
Overview
- Phase
- Not Applicable
- Intervention
- pegfilgrastim
- Conditions
- Sarcoma
- Sponsor
- Masonic Cancer Center, University of Minnesota
- Enrollment
- 70
- Locations
- 2
- Primary Endpoint
- Disease-free survival
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must have histologically confirmed, high grade, soft tissue sarcoma including
- •malignant fibrous histiocytoma,
- •liposarcoma,
- •fibrosarcoma,
- •leiomyosarcoma,
- •synovial carcinoma,
- •malignant peripheral nerve sheath tumor (MPNST),
- •epithelioid sarcoma, and
- •sarcomas-not otherwise specified.
- •NOTE: Ewings sarcoma, primitive neuroectodermal tumor, extraskeletal, osteosarcoma, extraskeletal chondrosarcoma, alveolar soft part sarcoma, rhabdomyosarcoma, carcinosarcoma, Kaposi's sarcoma, angiosarcoma, and mesothelioma patients are ineligible for this study.
Exclusion Criteria
- •Previous treatment with chemotherapy or radiation therapy
- •Females known to be pregnant or breast-feeding are excluded because PET/CT scan in pregnant women is not FDA approved.
- •Serious concomitant systemic disorders (eg, active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study. Patients with PET-CT as an indicator of disease survival in soft tissue sarcoma untreated or symptomatic CNS metastases or uncontrolled diabetes will not be eligible.
- •Patient must give written informed consent indicating the investigational nature of the study and its potential risks.
Arms & Interventions
Preferred Standard Regimen
Subjects with soft tissue sarcoma who are receiving pegylated liposomal doxorubicin hydrochloride, Ifosfamide with mesna and pegfilgrastim - Repeat every 28 days for 4 cycles total
Intervention: pegfilgrastim
Preferred Standard Regimen
Subjects with soft tissue sarcoma who are receiving pegylated liposomal doxorubicin hydrochloride, Ifosfamide with mesna and pegfilgrastim - Repeat every 28 days for 4 cycles total
Intervention: ifosfamide
Preferred Standard Regimen
Subjects with soft tissue sarcoma who are receiving pegylated liposomal doxorubicin hydrochloride, Ifosfamide with mesna and pegfilgrastim - Repeat every 28 days for 4 cycles total
Intervention: pegylated liposomal doxorubicin hydrochloride
Preferred Standard Regimen
Subjects with soft tissue sarcoma who are receiving pegylated liposomal doxorubicin hydrochloride, Ifosfamide with mesna and pegfilgrastim - Repeat every 28 days for 4 cycles total
Intervention: conventional surgery
Preferred Standard Regimen
Subjects with soft tissue sarcoma who are receiving pegylated liposomal doxorubicin hydrochloride, Ifosfamide with mesna and pegfilgrastim - Repeat every 28 days for 4 cycles total
Intervention: fludeoxyglucose F 18
Alternative Treatment Regimen
Subjects with soft tissue sarcoma who are receiving Doxorubicin hydrochloride, Ifosfamide with mesna and pegfilgrastim - Repeat every 28 days for 4 cycles total
Intervention: pegfilgrastim
Alternative Treatment Regimen
Subjects with soft tissue sarcoma who are receiving Doxorubicin hydrochloride, Ifosfamide with mesna and pegfilgrastim - Repeat every 28 days for 4 cycles total
Intervention: doxorubicin hydrochloride
Alternative Treatment Regimen
Subjects with soft tissue sarcoma who are receiving Doxorubicin hydrochloride, Ifosfamide with mesna and pegfilgrastim - Repeat every 28 days for 4 cycles total
Intervention: ifosfamide
Alternative Treatment Regimen
Subjects with soft tissue sarcoma who are receiving Doxorubicin hydrochloride, Ifosfamide with mesna and pegfilgrastim - Repeat every 28 days for 4 cycles total
Intervention: conventional surgery
Alternative Treatment Regimen
Subjects with soft tissue sarcoma who are receiving Doxorubicin hydrochloride, Ifosfamide with mesna and pegfilgrastim - Repeat every 28 days for 4 cycles total
Intervention: fludeoxyglucose F 18
Outcomes
Primary Outcomes
Disease-free survival
Time Frame: Baseline through Survival Event
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.
Secondary Outcomes
- Correlate histologic response with FDG-PET/CT imaging(At end of each cycle)
- Compare changes in FDG-PET/CT imaging with disease-free survival by max SUV calculations(Baseline Compared to 1 Cycle and Baseline to After Chemotherapy)