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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01170923

Enrollment

100

Registered

2010-07-28

Start date

2008-09-30

Completion date

Unknown

Last updated

2010-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Keywords

non small cell lung cancer, FDG PET

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.

Interventions

DEVICEFDR-PET

FDR-PET performed after 1 cycle of chemotherapy

DEVICECT

CT performed after 3 cycles of chemotherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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%.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026