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

Non-small Cell Lung Cancer Metastatic Clinical Trial

— PETRA  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02035683
• Other study ID #: PETRA
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2013
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: National Cancer Institute, Naples
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 220
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer Metastatic
• Non-small Cell Lung Cancer Stage IIIB

Intervention

Procedure:
• PET/CT
PET/CT scan at baseline and 3 weeks after first cycle chemotherapy

Locations

Country	Name	City	State
Italy	Istituto Nazionale dei Tumori	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Naples

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	overall survival		one year
Secondary	progression free survival		12 months
Secondary	objective response		3 months