Status:
COMPLETED
PET CT as Predictor of Response in Preoperative Chemotherapy for Soft Tissue Sarcoma
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Sarcoma
Eligibility:
All Genders
16+ years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 10 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2022
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00346125
Start Date
April 10 2006
End Date
July 1 2022
Last Update
December 15 2022
Active Locations (2)
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1
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
2
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455