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

NCT00346125 | Completed

• 2 other identifiers: 2005LS080UMN-0512M78446
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

Sarcoma

Keywords

soft tissue sarcoma; Malignant fibrous histiocytoma; Liposarcoma; Fibrosarcoma; Leiomyosarcoma; Synovial sarcoma; Malignant peripheral nerve sheath tumor (MPNST); Epithelioid sarcoma

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  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.

  Baseline through Survival Event

Secondary Outcomes (2)

• 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

Study Arms (2)

Preferred Standard Regimen

ACTIVE COMPARATOR

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

Biological: pegfilgrastim; Drug: ifosfamide; Drug: pegylated liposomal doxorubicin hydrochloride; Procedure: conventional surgery; Radiation: fludeoxyglucose F 18

Alternative Treatment Regimen

ACTIVE COMPARATOR

Subjects with soft tissue sarcoma who are receiving Doxorubicin hydrochloride, Ifosfamide with mesna and pegfilgrastim - Repeat every 28 days for 4 cycles total

Biological: pegfilgrastim; Drug: doxorubicin hydrochloride; Drug: ifosfamide; Procedure: conventional surgery; Radiation: fludeoxyglucose F 18

Interventions

pegfilgrastim BIOLOGICAL

will be given at 6 mg subcutaneously (SC) at the end of the mesna infusion

Also known as: Neulasta(R)

Alternative Treatment Regimen; Preferred Standard Regimen

doxorubicin hydrochloride DRUG

65 mg/m\^2 by continuous intravenous (IV) infusion over 7 days beginning on day 1

Also known as: Doxorubicin, Adriamycin

Alternative Treatment Regimen

ifosfamide DRUG

9 g/m\^2 by continuous intravenous (IV) infusion over 6 days beginning on day 1 with mesna 10.5 g/m\^2 by continuous IV infusion over 7 days beginning on day 1

Also known as: Mitoxana, Ifex

Alternative Treatment Regimen; Preferred Standard Regimen

pegylated liposomal doxorubicin hydrochloride DRUG

45 mg/m2 intravenous (IV) Day 1, repeat every 28 days.

Also known as: doxorubicin-hydrochloride-liposome

Preferred Standard Regimen

conventional surgery PROCEDURE

The surgical procedure will be decided by the treating physician and independent of study participation

Alternative Treatment Regimen; Preferred Standard Regimen

fludeoxyglucose F 18 RADIATION

FDG is a radioactive sugar equal to a uniform whole-body exposure of approximately 1.5 rem for each scan. Post-operative radiation therapy may be given according to institutional guidelines in patients felt to have close surgical margins.

Also known as: FDG

Alternative Treatment Regimen; Preferred Standard Regimen

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (2)

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• O'Donnell PW, Manivel JC, Cheng EY, Clohisy DR. Chemotherapy influences the pseudocapsule composition in soft tissue sarcomas. Clin Orthop Relat Res. 2014 Mar;472(3):849-55. doi: 10.1007/s11999-013-3022-7.

  PMID: 23640206 DERIVED

MeSH Terms

Conditions

Sarcoma; Histiocytoma, Malignant Fibrous; Liposarcoma; Fibrosarcoma; Leiomyosarcoma; Sarcoma, Synovial; Neurofibrosarcoma

Interventions

pegfilgrastim; Doxorubicin; Ifosfamide; Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Histiocytoma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Adipose Tissue; Neoplasms, Muscle Tissue; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Peripheral Nervous System Neoplasms; Nervous System Neoplasms; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyglucose; Deoxy Sugars

Study Officials

• Edward Cheng, MD

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2006
• First Posted: June 29, 2006
• Study Start: April 10, 2006
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2022
• Last Updated: December 15, 2022

Record last verified: 2022-12

Locations

US (2)