An Evaluation of PET/CT Imaging as a Predictor of Disease Free Survival Following Neo-Adjuvant Chemotherapy for Soft Tissue Sarcoma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 70
- Locations
- 2
- Primary Endpoint
- Disease-free survival
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •Measurable disease using traditional cross section measurements with the primary site's largest diameter > 5 centimeters by positron emission tomography/computated tomography (PET/CT), CT or magnetic resonance imaging (MRI) scan. Patients with either localized (primary or locally recurrent) or metastatic disease at presentation are eligible for study if they are to receive neoadjuvant treatment prior to excision of the primary (stage IIC, III, IVA, IVB.)
- •Age ≥ 16 years, Karnofsky ≥ 70%
- •Adequate organ function for receiving chemotherapy as determined by the treating physician.
- •Women of childbearing potential and sexually active males are required to use an effective method of contraception (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) during the 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 (Biological)
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 (Drug)
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 (Drug)
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 (Procedure)
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 (Radiation)
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 (Biological)
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 (Drug)
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 (Drug)
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 (Procedure)
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 (Radiation)
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)