Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatments fdr-pet, ct
Phase phase 2
Sponsor Asan Medical Center
Collaborator Boryung Pharmaceutical Co., Ltd
Start date September 2008
End date August 2010
Trial size 100 participants
Trial identifier NCT01170923, AMC 08-351

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Chemotherapy regimen will be changed depending on metabolic response.
fdr-pet
FDR-PET performed after 1 cycle of chemotherapy
(Active Comparator)
Chemotherapy regimen will be changed depending on CT findings (RECIST).
ct
CT performed after 3 cycles of chemotherapy

Primary Outcomes

Measure
change in response rate
time frame: within 4 cycles

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Principal investigator Sang-We Kim, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2010.
Information provided to ClinicalTrials.gov by Asan Medical Center.