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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01170923
• Other study ID #: AMC 08-351
• Status: Active, not recruiting
• Phase: Phase 2
• First received: July 27, 2010
• Last updated: July 27, 2010
• Start date: September 2008

Study information

• Verified date: July 2010
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Device:
• FDR-PET
FDR-PET performed after 1 cycle of chemotherapy
• CT
CT performed after 3 cycles of chemotherapy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	Boryung Pharmaceutical Co., Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in response rate	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	No