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

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.