Study of the Role of Metabolic Response Measured by PET/CT Scan After 1 Cycle of Chemotherapy in Patients With Advanced Non Small Cell Lung Cancer (NSCLC)

National Cancer Institute, Naples1 site in 1 country220 target enrollmentOctober 2013

ConditionsNon-small Cell Lung Cancer Metastatic Non-small Cell Lung Cancer Stage IIIB

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Non-small Cell Lung Cancer Metastatic
Sponsor: National Cancer Institute, Naples
Enrollment: 220
Locations: 1
Primary Endpoint: change from baseline in highest value SUVmax (maximum standardized uptake values in PET/CT scan)
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to test whether an early metabolic response, measured by PET/CT scan after the first cycle of chemotherapy, is able to predict which patients with advanced NSCLC have a better prognosis.

Registry

clinicaltrials.gov

Start Date

October 2013

End Date

December 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

National Cancer Institute, Naples

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Diagnosis of cytologically or histologically confirmed non-small cell lung cancer.
•Metastatic (stage IV, both M1A or M1B) or locally advanced (stage IIIB, with metastasis to supraclavicular nodes) according to TNM VII edition.
•Both patients at first diagnosis or those with disease recurrence after initial surgery are eligible.
•At least one target or non-target lesion according to RECIST revised version 1.
•Age \> or = 18 years .
•ECOG PS 0-
•Life expectancy \> 3 months.
•Signed informed consent.

Exclusion Criteria

•Uncontrolled diabetes (glucose \> 200 mg/dl
•EGFR mutation, for those patients who have had testing done. (EGFR test is not required for participation in the study, but may be conducted as part of normal clinical practice, and patients with EGFR mutation would not be candidate for first-line chemotherapy.)
•Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer or surgically resected prostate cancer with normal PSA).
•Pregnant or lactating females.
•Previous medical therapy for metastatic disease (prior surgery, radiation therapy are permitted, as well as adjuvant medical therapy completed at least 6 months prior to study entry).
•Any poorly controlled illness (including active infections, significant hepatic, renal, metabolic or cardiac disease, myocardial infarction within previous 12 months) that may, according to physician's judgement, interfere with the patient's ability to undergo chemotherapy and/or the examinations within the study protocol
•Inability to provide informed consent.

Outcomes

Primary Outcomes

change from baseline in highest value SUVmax (maximum standardized uptake values in PET/CT scan)

Time Frame: one year

To validate as prognostic factor, in terms of overall survival,early metabolic response, defined as a reduction of more than 50% of the highest value of SUVmax recorded at PET/CT scan after one cycle of chemotherapy, compared to the highest value of SUVmax recorded baseline examination

Secondary Outcomes

objective response(3 months)
Change from baseline in SUVmaxsum, TLGmax and TLGmaxsum(one year)
overall survival(one year)
correlation among SUVmax, SUVmaxsum, TLGmax, TLGsum with progression-free survival(one year)
correlation among SUVmax, SUVmaxsum, TLGmax, TLGsum with objective response(3 months)
progression free survival(12 months)