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

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ClinicalTrials.gov Identifier: NCT02035683
Recruitment Status : Unknown
Verified March 2017 by National Cancer Institute, Naples.
Recruitment status was:  Recruiting
First Posted : January 14, 2014
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples

Study Description
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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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Metastatic Non-small Cell Lung Cancer Stage IIIB Procedure: PET/CT Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2013
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : July 2018

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Arms and Interventions
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Arm Intervention/treatment
Advanced NSCLC patients undergoing first-line chemotherapy
single cohort
 Procedure: PET/CT
PET/CT scan at baseline and 3 weeks after first cycle chemotherapy


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change from baseline in SUVmaxsum, TLGmax and TLGmaxsum [ Time Frame: one year ]
    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).

  2. correlation among SUVmax, SUVmaxsum, TLGmax, TLGsum with progression-free survival [ Time Frame: one year ]
    prognostic role of early metabolic response (defined according the above reported 4 parameters) in terms of progression free survival after a first line chemotherapy

  3. correlation among SUVmax, SUVmaxsum, TLGmax, TLGsum with objective response [ Time Frame: 3 months ]
    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

  4. overall survival [ Time Frame: one year ]
  5. progression free survival [ Time Frame: 12 months ]
  6. objective response [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02035683


Contacts
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Contact: Francesco Perrone, M.D., Ph.D. +39 081 5903571 francesco.perrone@usc-intnapoli.net
Contact: Maria Carmela Piccirillo, M.D. +39 081 5903383 marilina.piccirillo@usc-intnapoli.net

Locations
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Italy
Istituto Nazionale dei Tumori Recruiting
Napoli, Italy
Sponsors and Collaborators
National Cancer Institute, Naples
Investigators
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Principal Investigator: 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
More Information
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Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT02035683    
Other Study ID Numbers: PETRA
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017
Keywords provided by National Cancer Institute, Naples:
metabolic response
chemotherapy
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms