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

Phase 2

• Conditions: Non-small Cell Lung Cancer
• Interventions: Device: FDR-PET; Device: CT

• Registration Number: NCT01170923
• Lead Sponsor: Asan Medical Center

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.

Study Timeline

• Study Start: 2008-09
• Status Verified: 2010-07
• Study First Submitted: 2010-07-27
• Study First Submitted QC: 2010-07-27
• Last Update Submitted: 2010-07-27
• Study First Posted: 2010-07-28
• Last Update Posted: 2010-07-28
• Primary Completion: 2010-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

7. 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.

8. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FDG-PET guided	FDR-PET	Chemotherapy regimen will be changed depending on metabolic response.
CT guided	CT	Chemotherapy regimen will be changed depending on CT findings (RECIST).

Primary Outcome Measures

Name	Time	Method
change in response rate	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%.