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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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FDG-PET guided

Chemotherapy regimen will be changed depending on metabolic response.

Group Type EXPERIMENTAL

FDR-PET

Intervention Type DEVICE

FDR-PET performed after 1 cycle of chemotherapy

CT guided

Chemotherapy regimen will be changed depending on CT findings (RECIST).

Group Type ACTIVE_COMPARATOR

CT

Intervention Type DEVICE

CT performed after 3 cycles of chemotherapy

Interventions

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FDR-PET

FDR-PET performed after 1 cycle of chemotherapy

Intervention Type DEVICE

CT

CT performed after 3 cycles of chemotherapy

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No