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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Asan Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Boryung Pharmaceutical Co., Ltd
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01170923
First received: July 27, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Non-small Cell Lung Cancer
 Device: FDR-PET
Device: CT
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • change in response rate [ Time Frame: within 4 cycles ] [ Designated as safety issue: No ]
    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%.


Estimated Enrollment: 100
Study Start Date: September 2008
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FDG-PET guided
Chemotherapy regimen will be changed depending on metabolic response.
 Device: FDR-PET
FDR-PET performed after 1 cycle of chemotherapy
Active Comparator: CT guided
Chemotherapy regimen will be changed depending on CT findings (RECIST).
 Device: CT
CT performed after 3 cycles of chemotherapy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01170923

Sponsors and Collaborators
Asan Medical Center
Boryung Pharmaceutical Co., Ltd
Investigators
Principal Investigator: Sang-We Kim, MD Asan Medical Center
  More Information

No publications provided

Responsible Party: Sang-We Kim, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01170923     History of Changes
Other Study ID Numbers: AMC 08-351
Study First Received: July 27, 2010
Last Updated: July 27, 2010
Health Authority: South Korea: Institutional Review Board

Keywords provided by Asan Medical Center:
non small cell lung cancer
FDG PET

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013