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FDG-PET Scan Response Guided Chemotherapy Strategy for Advanced Non-small Cell Lung Cancer

Primary Purpose

Non-small Cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
FDR-PET
CT
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Non-small Cell Lung Cancer focused on measuring non small cell lung cancer, FDG PET

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Histologically confirmed non-small cell carcinoma.
  2. Stage IIIB (wet) or IV advanced NSCLC.
  3. No evidence of prior malignancies for 3 years except treated basal cell or squamous cell carcinoma of skin and carcinoma in situ of uterine cervix.
  4. Measurable disease by RECIST criteria.

  5. Adequate organ function as follows.

    • Seum AST/ALT < 2.5 x Upper normal limit (UNL) (if hepatic metastasis < 5 x UNL)
    • Total bilirubin < 1.5 x UNL
    • Serum creatinine < 1.5 mg/dL
    • Absolute neutrophil count > 1500/uL
    • Platelet > 100,000/uL
    • Hemoglobin > 9.0 g/dL
  6. ECOG Performance status 0-1 7 Age > 18

8. If previously treated with major surgery, it should be over at least 4 weeks. And if previously treated with radiotherapy, it should be over at least 2 weeks.

9. Written consent

Exclusion Criteria:

  1. Previous chemotherapy.
  2. Symptomatic brain metastasis.
  3. Concurrent severe medical illness.
  4. Pregnancy and lactation.

  5. If there are findings which may increase risk with chemotherapy or inhibit to analyze the result of clinical trial.

    • Uncontrolled diabetes mellitus.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    FDG-PET guided

    CT guided

    Arm Description

    Chemotherapy regimen will be changed depending on metabolic response.

    Chemotherapy regimen will be changed depending on CT findings (RECIST).

    Outcomes

    Primary Outcome Measures

    change in response rate
    The usual response rate of GenexolPM/Cisplatin chemotherapy is 30-40%. This trial will assess whether the changing chemotherapy strategy using FDG-PET can increase response rate by 15%.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 27, 2010
    Last Updated
    July 27, 2010
    Sponsor
    Asan Medical Center
    Collaborators
    Boryung Pharmaceutical Co., Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01170923
    Brief Title
    FDG-PET Scan Response Guided Chemotherapy Strategy for Advanced Non-small Cell Lung Cancer
    Official Title
    Standard Chemotherapy Strategy Versus Changing Chemotherapy Strategy as to FDG-PET Response After 1st Cycle of Standard Chemotherapy for Advanced Non-small Cell Lung Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2010
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2008 (undefined)
    Primary Completion Date
    August 2010 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Asan Medical Center
    Collaborators
    Boryung Pharmaceutical Co., Ltd

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The usual response to chemotherapy is decided through the image change by computed tomography (CT), which is taken at least 6-9 weeks. In order to predict the response to chemotherapy earlier, patients received FDG-PET scan at the first cycle of chemotherapy. Chemotherapy was guided by the metabolic response by FDG-PET scan.
    Detailed Description
    Prospective, Open-label, Randomized phase II, single institution trial that compared chemotherapy guided by traditional evaluation based on RECIST versus chemotherapy guided by FDG-PET (metabolic) response.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-small Cell Lung Cancer
    Keywords
    non small cell lung cancer, FDG PET

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    FDG-PET guided
    Arm Type
    Experimental
    Arm Description
    Chemotherapy regimen will be changed depending on metabolic response.
    Arm Title
    CT guided
    Arm Type
    Active Comparator
    Arm Description
    Chemotherapy regimen will be changed depending on CT findings (RECIST).
    Intervention Type
    Device
    Intervention Name(s)
    FDR-PET
    Intervention Description
    FDR-PET performed after 1 cycle of chemotherapy
    Intervention Type
    Device
    Intervention Name(s)
    CT
    Intervention Description
    CT performed after 3 cycles of chemotherapy
    Primary Outcome Measure Information:
    Title
    change in response rate
    Description
    The usual response rate of GenexolPM/Cisplatin chemotherapy is 30-40%. This trial will assess whether the changing chemotherapy strategy using FDG-PET can increase response rate by 15%.
    Time Frame
    within 4 cycles

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Histologically confirmed non-small cell carcinoma. Stage IIIB (wet) or IV advanced NSCLC. No evidence of prior malignancies for 3 years except treated basal cell or squamous cell carcinoma of skin and carcinoma in situ of uterine cervix. Measurable disease by RECIST criteria. Adequate organ function as follows. Seum AST/ALT < 2.5 x Upper normal limit (UNL) (if hepatic metastasis < 5 x UNL) Total bilirubin < 1.5 x UNL Serum creatinine < 1.5 mg/dL Absolute neutrophil count > 1500/uL Platelet > 100,000/uL Hemoglobin > 9.0 g/dL ECOG Performance status 0-1 7 Age > 18 8. If previously treated with major surgery, it should be over at least 4 weeks. And if previously treated with radiotherapy, it should be over at least 2 weeks. 9. Written consent Exclusion Criteria: Previous chemotherapy. Symptomatic brain metastasis. Concurrent severe medical illness. Pregnancy and lactation. If there are findings which may increase risk with chemotherapy or inhibit to analyze the result of clinical trial. Uncontrolled diabetes mellitus.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sang-We Kim, MD
    Organizational Affiliation
    Asan Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    FDG-PET Scan Response Guided Chemotherapy Strategy for Advanced Non-small Cell Lung Cancer

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