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

NCT02035683 | Unknown

• 1 other identifier: PETRA
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

metabolic response; chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change from baseline in SUVmaxsum, TLGmax and TLGmaxsum

  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

• overall survival

  one year

• progression free survival

  12 months

Study Arms (1)

Advanced NSCLC patients undergoing first-line chemotherapy

OTHER

single cohort

Procedure: PET/CT

Interventions

PET/CT PROCEDURE

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

Advanced NSCLC patients undergoing first-line chemotherapy

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Study Sites (1)

Istituto Nazionale dei Tumori

Napoli, Italy

Location

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

• Secondo Lastoria, M.D.

  National Cancer Institute, Naples

  PRINCIPAL INVESTIGATOR

• Francesco Perrone, M.D., Ph.D

  National Cancer Institute Naples, Italy; Director Clinical Trials Unit

  PRINCIPAL INVESTIGATOR

• Ciro Gallo, M.D., Ph.D

  Second University of Naples, Italy; Chair of Medical Statistics

  PRINCIPAL INVESTIGATOR

• Massimo Di Maio, 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: January 14, 2014
• Study Start: October 1, 2013
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

IT (1)