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

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Masonic Cancer Center, University of Minnesota
• Treatments: Doxorubicin; Fluorodeoxyglucose F18; Ifosfamide; Isophosphamide mustard; Liposomal doxorubicin

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.

• 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.