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

Sponsor
Masonic Cancer Center, University of Minnesota (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00346125
Collaborator
(none)
70
2
2
193
35
0.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: pegfilgrastim
  • Drug: doxorubicin hydrochloride
  • Drug: ifosfamide
  • Drug: pegylated liposomal doxorubicin hydrochloride
  • Procedure: conventional surgery
  • Radiation: fludeoxyglucose F 18
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Apr 1, 2006
Actual Primary Completion Date :
Jul 1, 2013
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • FDG
  • Outcome Measures

    Primary Outcome Measures

    1. Disease-free survival [Baseline through Survival Event]

      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

    1. Correlate histologic response with FDG-PET/CT imaging [At end of each cycle]

      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

    2. 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]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Sinai Hospital of Baltimore Baltimore Maryland United States 21215
    2 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Masonic Cancer Center, University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT00346125
    Other Study ID Numbers:
    • 2005LS080
    • UMN-0512M78446
    First Posted:
    Jun 29, 2006
    Last Update Posted:
    Apr 4, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Masonic Cancer Center, University of Minnesota
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 4, 2022