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

Asan Medical Center

Status and phase: Unknown; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Device: FDR-PET; Device: CT

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01170923

AMC 08-351

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

FDG-PET guided

Experimental group

Description:

Chemotherapy regimen will be changed depending on metabolic response.

Treatment:

Device: FDR-PET

CT guided

Active Comparator group

Description:

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

Treatment:

Device: CT