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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00346125
First received: June 28, 2006
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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:


Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: Baseline through Survival Event ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Correlate histologic response with FDG-PET/CT imaging [ Time Frame: At end of each cycle ] [ Designated as safety issue: No ]

    The overall histologic response will be defined as:

    % histologic response = 100 - % viable tumor in the central slice as assessed histologically It should be noted that the % histologic response is different from % tumor necrosis as it includes an assessment of the % tumor necrosis along with the degenerative changes


  • Compare changes in FDG-PET/CT imaging with disease-free survival by max SUV calculations [ Time Frame: Baseline Compared to 1 Cycle and Baseline to After Chemotherapy ] [ Designated as safety issue: No ]
    Changes in PET/CT from baseline will be compared to PET/CT done after one cycle and after completion of chemotherapy treatment before surgical excision using max SUV calculations.


Enrollment: 70
Study Start Date: April 2006
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Preferred Standard Regimen
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
will be given at 6 mg subcutaneously (SC) at the end of the mesna infusion
Other Name: Neulasta(R)
Drug: ifosfamide
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
Other Names:
  • Mitoxana
  • Ifex
Drug: pegylated liposomal doxorubicin hydrochloride
45 mg/m2 intravenous (IV) Day 1, repeat every 28 days.
Other Name: doxorubicin-hydrochloride-liposome
Procedure: conventional surgery
The surgical procedure will be decided by the treating physician and independent of study participation
Radiation: fludeoxyglucose F 18
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.
Other Name: FDG
Active Comparator: Alternative Treatment Regimen
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
will be given at 6 mg subcutaneously (SC) at the end of the mesna infusion
Other Name: Neulasta(R)
Drug: doxorubicin hydrochloride
65 mg/m^2 by continuous intravenous (IV) infusion over 7 days beginning on day 1
Other Names:
  • Doxorubicin
  • Adriamycin
Drug: ifosfamide
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
Other Names:
  • Mitoxana
  • Ifex
Procedure: conventional surgery
The surgical procedure will be decided by the treating physician and independent of study participation
Radiation: fludeoxyglucose F 18
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.
Other Name: FDG

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

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Maryland
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
United States, Minnesota
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Principal Investigator: Edward Cheng, MD Masonic Cancer Center, University of Minnesota
  More Information

Additional Information:
No publications provided by Masonic Cancer Center, University of Minnesota

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00346125     History of Changes
Other Study ID Numbers: 2005LS080, UMN-0512M78446
Study First Received: June 28, 2006
Last Updated: December 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Masonic Cancer Center, University of Minnesota:
soft tissue sarcoma
Malignant fibrous histiocytoma
Liposarcoma
Fibrosarcoma
Leiomyosarcoma
Synovial sarcoma
Malignant peripheral nerve sheath tumor (MPNST)
Epithelioid sarcoma

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Doxorubicin
Isophosphamide mustard
Ifosfamide
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014