PET Scan Combined With CT Scan in Predicting Response in Patients Undergoing Chemotherapy and Surgery for Soft Tissue Sarcoma - Full Text View

Sponsor:	Masonic Cancer Center, University of Minnesota
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00346125

Purpose

RATIONALE: Diagnostic procedures, such as PET scan and 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.

Condition	Intervention
Sarcoma	Biological: pegfilgrastim Drug: doxorubicin hydrochloride Drug: ifosfamide Drug: pegylated liposomal doxorubicin hydrochloride Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: fludeoxyglucose F 18

Study Type:	Interventional
Study Design:	Diagnostic, Open Label
Official Title:	An Evaluation of PET/CT Imaging as a Predictor of Disease Free Survival Following Neo-Adjuvant Chemotherapy for Soft Tissue Sarcoma

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Cancer Nuclear Scans Soft Tissue Sarcoma Surgery

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Fluorodeoxyglucose F18 Pegfilgrastim Ifosfamide

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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 [ Designated as safety issue: No ]

Secondary Outcome Measures:

Correlate histologic response with FDG-PET/CT imaging [ Designated as safety issue: No ]
Compare changes in FDG-PET/CT imaging with disease-free survival by max SUV calculations [ Designated as safety issue: No ]
PET/CT imaging by max SUV calculations at baseline, course 1, and after completion of chemotherapy [ Designated as safety issue: No ]

Estimated Enrollment:	62
Study Start Date:	April 2006
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

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.

Tertiary

Determine the changes in FDG-PET/CT imaging over time as each course of chemotherapy is given.

OUTLINE: Patients receive 1 of 2 standard chemotherapy regimens:

Preferred regimen: Patients receive pegylated doxorubicin HCl liposome IV on day 1, ifosfamide IV continuously on days 1-6, and pegfilgrastim subcutaneously (SC) on day 8. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Alternative regimen: Patients receive doxorubicin hydrochloride IV continuously on days 1-7. Patients also receive ifosfamide and pegfilgrastim as in the preferred regimen. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

All patients undergo a fludeoxyglucose positron emission tomography/CT scan at baseline, after course 1, and after completion of chemotherapy. Patients undergo surgery within 4-6 weeks after completion of chemotherapy.

After completion of study treatment and surgery, patients are followed every 6 months for 5 years.

PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed stage IIC, III, IVA, or IVB soft tissue sarcoma
- Any of the following cell types are allowed:
  - Malignant fibrous histiocytoma
  - Liposarcoma
  - Fibrosarcoma
  - Leiomyosarcoma
  - Synovial sarcoma
  - Malignant peripheral nerve sheath tumor (MPNST)
  - Epithelioid sarcoma
  - Sarcomas not otherwise specified
- The following cell types are not allowed:
  - Ewing's sarcoma
  - Primitive neuroectodermal tumor
  - Extraskeletal osteosarcoma
  - Extraskeletal chondrosarcoma
  - Alveolar soft part sarcoma
  - Rhabdomyosarcoma
  - Carcinosarcoma
  - Kaposi's sarcoma
  - Angiosarcoma
  - Mesothelioma
Localized (primary or locally recurrent) or metastatic disease allowed
Measurable disease, as defined by largest diameter of primary site > 5 cm by x-ray, CT scan or MRI
Resectable disease or not amenable to surgical cure
No untreated or symptomatic CNS metastases

PATIENT CHARACTERISTICS:

Karnofsky performance status 70-100%
Adequate organ function for receiving chemotherapy
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No active infection
No uncontrolled diabetes
No other serious concurrent systemic disorders that, in the opinion of the investigator, would compromise the safety of the patient or the patient's ability to complete the study

PRIOR CONCURRENT THERAPY:

No previous treatment with chemotherapy or radiotherapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00346125

Locations

United States, Minnesota
Masonic Cancer Center at University of Minnesota	Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620

Sponsors and Collaborators

Masonic Cancer Center, University of Minnesota

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Edward Cheng, MD

Masonic Cancer Center, University of Minnesota

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000482407, UMN-2005LS080, UMN-0512M78446
Study First Received:	June 28, 2006
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00346125 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

adult malignant fibrous histiocytoma
adult epithelioid sarcoma
adult fibrosarcoma
adult leiomyosarcoma
adult liposarcoma
adult neurofibrosarcoma
adult synovial sarcoma

dermatofibrosarcoma protuberans
stage II adult soft tissue sarcoma
stage III adult soft tissue sarcoma
stage IV adult soft tissue sarcoma
adult malignant hemangiopericytoma
adult malignant mesenchymoma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antibiotics, Antineoplastic
Doxorubicin
Pharmacologic Actions
Neoplasms, Connective and Soft Tissue

Neoplasms
Ifosfamide
Therapeutic Uses
Sarcoma
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on December 29, 2009