PET/CT Scan as a Tool to Rationalize the Treatment of of Advanced NSCLC Patients Undergoing First Chemotherapy (PETRA)

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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Non-small Cell Lung Cancer Metastatic; Non-small Cell Lung Cancer Stage IIIB
• Intervention / Treatment: Procedure: PET/CT

• Study Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Napoli, Italy
    • Istituto Nazionale dei Tumori

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Advanced NSCLC patients undergoing first-line chemotherapy; single cohort	Procedure: PET/CT; PET/CT scan at baseline and 3 weeks after first cycle chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline in highest value SUVmax (maximum standardized uptake values in PET/CT scan)	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	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival		one year
progression free survival		12 months
correlation among SUVmax, SUVmaxsum, TLGmax, TLGsum with objective response	To describe the association between early metabolic response (defined according the above reported 4 parameters) and objective response according RECIST criteria, measured after 3 cycles of chemotherapy	3 months
Change from baseline in SUVmaxsum, TLGmax and TLGmaxsum	to describe and validate early metabolic response as a prognostic factor (in terms of overall survival), using the sum of the SUVmax (SUVmaxsum) , the highest value of TLG (TLGmax), the sum of TLG ( TLGmaxsum).	one year
correlation among SUVmax, SUVmaxsum, TLGmax, TLGsum with progression-free survival	prognostic role of early metabolic response (defined according the above reported 4 parameters) in terms of progression free survival after a first line chemotherapy	one year
objective response		3 months

Collaborators and Investigators

• Sponsor: National Cancer Institute, Naples
• Investigators: Principal Investigator: Secondo Lastoria, M.D., National Cancer Institute, Naples; Principal Investigator: Alessandro Morabito, M.D., National Cancer Institute, Naples; Principal Investigator: Gaetano Rocco, M.D., National Cancer Institute, Naples

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: January 7, 2014
• First Submitted That Met QC Criteria: January 13, 2014
• First Posted (Estimate): January 14, 2014

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: chemotherapy; metabolic response
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: PETRA