Clinical trial NCT02035683: PET/CT Scan as a Tool to Rationalize the Treatment of of Advanced NSCLC Patients Undergoing First Chemotherapy
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-small Cell Lung Cancer Metastatic
Non-small Cell Lung Cancer Stage IIIB
Keywords: metabolic response
chemotherapy
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2014-01-14
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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 1.1.
* Age \> or = 18 years .
* ECOG PS 0-2.
* 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.

Primary outcomes:
measure: change from baseline in highest value SUVmax (maximum standardized uptake values in PET/CT scan)
timeFrame: one year
Secondary outcomes:
measure: Change from baseline in SUVmaxsum, TLGmax and TLGmaxsum
timeFrame: one year
measure: correlation among SUVmax, SUVmaxsum, TLGmax, TLGsum with progression-free survival
timeFrame: one year
measure: correlation among SUVmax, SUVmaxsum, TLGmax, TLGsum with objective response
timeFrame: 3 months
measure: overall survival
timeFrame: one year
measure: progression free survival
timeFrame: 12 months
measure: objective response
timeFrame: 3 months
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Istituto Nazionale dei Tumori
Study officials:
affiliation: National Cancer Institute, Naples
name: Secondo Lastoria, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute Naples, Italy; Director Clinical Trials Unit
name: Francesco Perrone, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Second University of Naples, Italy; Chair of Medical Statistics
name: Ciro Gallo, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Naples
name: Massimo Di Maio, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Naples
name: Alessandro Morabito, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Naples
name: Gaetano Rocco, M.D.
role: PRINCIPAL_INVESTIGATOR
References: