PET/CT Scan as a Tool to Rationalize the Treatment of of Advanced NSCLC Patients Undergoing First Chemotherapy
Launched by NATIONAL CANCER INSTITUTE, NAPLES · Jan 13, 2014
Trial Information
Current as of July 24, 2025
Unknown status
Keywords
ClinConnect Summary
No description provided
Gender
ALL
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.
About National Cancer Institute, Naples
The National Cancer Institute (NCI) in Naples is a leading research institution dedicated to advancing the understanding and treatment of cancer through innovative clinical trials. As a prominent sponsor of cancer research, the NCI focuses on developing novel therapies, improving patient outcomes, and exploring cutting-edge methodologies in oncology. With a commitment to scientific rigor and collaboration, the NCI in Naples engages in partnerships with academic institutions and healthcare providers to facilitate groundbreaking studies that address critical challenges in cancer care. Their mission is to translate research findings into effective treatments, ultimately enhancing the lives of patients affected by cancer.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Napoli, , Italy
Patients applied
Trial Officials
Secondo Lastoria, M.D.
Principal Investigator
National Cancer Institute, Naples
Francesco Perrone, M.D., Ph.D
Principal Investigator
National Cancer Institute Naples, Italy; Director Clinical Trials Unit
Ciro Gallo, M.D., Ph.D
Principal Investigator
Second University of Naples, Italy; Chair of Medical Statistics
Massimo Di Maio, M.D.
Principal Investigator
National Cancer Institute, Naples
Alessandro Morabito, M.D.
Principal Investigator
National Cancer Institute, Naples
Gaetano Rocco, M.D.
Principal Investigator
National Cancer Institute, Naples
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials