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

NCT01170923 | Unknown Phase 2

• 1 other identifier: AMC 08-351
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-small Cell Lung Cancer

Keywords

non small cell lung cancer; FDG PET

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

FDG-PET guided

EXPERIMENTAL

Chemotherapy regimen will be changed depending on metabolic response.

Device: FDR-PET

CT guided

ACTIVE COMPARATOR

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

Device: CT

Interventions

FDR-PET DEVICE

FDR-PET performed after 1 cycle of chemotherapy

FDG-PET guided

CT DEVICE

CT performed after 3 cycles of chemotherapy

CT guided

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed non-small cell carcinoma.
• Stage IIIB (wet) or IV advanced NSCLC.
• 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.
• Measurable disease by RECIST criteria.
• 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
• ECOG Performance status 0-1 7 Age \> 18
• \. 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.
• \. Written consent

You may not qualify if:

• Previous chemotherapy.
• Symptomatic brain metastasis.
• Concurrent severe medical illness.
• Pregnancy and lactation.
• If there are findings which may increase risk with chemotherapy or inhibit to analyze the result of clinical trial.
• Uncontrolled diabetes mellitus.

Sponsors & Collaborators

• Asan Medical Center: lead
• Boryung Pharmaceutical Co., Ltd: collaborator

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sang-We Kim, MD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 27, 2010
• First Posted: July 28, 2010
• Study Start: September 1, 2008
• Primary Completion: August 1, 2010
• Last Updated: July 28, 2010

Record last verified: 2010-07