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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. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by Asan Medical Center.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01170923
First Posted: July 28, 2010
Last Update Posted: July 28, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Boryung Pharmaceutical Co., Ltd
Information provided by:
Asan Medical Center
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • change in response rate [ Time Frame: within 4 cycles ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01170923


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

Responsible Party: Sang-We Kim, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01170923     History of Changes
Other Study ID Numbers: AMC 08-351
First Submitted: July 27, 2010
First Posted: July 28, 2010
Last Update Posted: July 28, 2010
Last Verified: July 2010

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

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