- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01170923
FDG-PET Scan Response Guided Chemotherapy Strategy for Advanced Non-small Cell Lung Cancer
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FDG-PET guided
Chemotherapy regimen will be changed depending on metabolic response.
|
FDR-PET performed after 1 cycle of chemotherapy
|
Active Comparator: CT guided
Chemotherapy regimen will be changed depending on CT findings (RECIST).
|
CT performed after 3 cycles of chemotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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%.
|
within 4 cycles
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sang-We Kim, MD, Asan Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AMC 08-351
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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