Clinical trial NCT04208854: Observational Study With Metronomic Oral Vinorelbine in Elderly Patients With Locally Advanced / Metastatic Non-small-cell Lung Cancer (NSCLC)
Official title: Observational Study With Metronomic Oral Vinorelbine in Elderly Patients With Locally Advanced / Metastatic Non-small-cell Lung Cancer (NSCLC)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Locally Advanced/ Metastatic NSCLC
Lead sponsor: International Group of Endovascular Oncology
Sponsor class: OTHER
Collaborators: name: Azienda Sanitaria Ospedaliera
First posted: 2019-12-23
Enrollment: 40
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ELDERLY PATIENTS \<70 YEARS OLD

Brief summary: Vinorelbine is the first line reference drug in the elderly patient with locally advanced / metastatic non-small-cell lung cancer (NSCLC). The introduction of the oral formulation of vinorelbine has determined a further impulse to its use in 1st line and above all to its use as "metronomic" therapy. Metronomic chemotherapy offers the advantage of increasing the overall dosage of the drug administered, but reducing the side effects or making them more easily manageable; it is practically a question of administering fractionated doses of the drug continuously for long periods (generally up to the progression of unacceptable disease or toxicity). This study collects data on the efficacy and tolerability of oral metronomic vinorelbine in elderly patients with NSCLC, performed as per normal clinical practice.

Detailed description: Vinorelbine is the first line reference drug in the elderly patient with locally advanced / metastatic non-small-cell lung cancer (NSCLC). The introduction of the oral formulation of vinorelbine has determined a further impulse to its use in 1st line and above all to its use as "metronomic" therapy. Metronomic chemotherapy offers the advantage of increasing the overall dosage of the drug administered, but reducing the side effects or making them more easily manageable; it is practically a question of administering fractionated doses of the drug continuously for long periods (generally up to the progression of unacceptable disease or toxicity). This study collects data on the efficacy and tolerability of oral metronomic vinorelbine in elderly patients with NSCLC, performed as per normal clinical practice.

Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of histologically documented NSCLC (adenocarcinoma and squamous carcinoma), stage IIIB (not eligible for surgery or chemo-radiotherapy) and stage IV according to the 8th edition of TNM
* "Wild type" for EGFR, ALK and PDL-1
* Age ≥ 70 years
* PS 0 - 2
* Adequate medullary reserve (neutrophils\> 1500; PLT\> 100,000 mm3); hepatic / renal function preserved
* Written informed consent

Exclusion Criteria:

* Gastrointestinal disorders that contraindicate the intake of the capsules (type ulcerative colitis or Chron's disease).
* Performance Status ECOG ≥ 3

Primary outcomes:
measure: TUMOR RESPONSE
timeFrame: 6 MONTHS
measure: number of adverse events
timeFrame: 6 MONTHS
Secondary outcomes:
measure: PFS
timeFrame: 1 year
measure: OS
timeFrame: 1 YEAR
Other outcomes:
Locations:
city: Pesaro
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord
state: Yes
Study officials:
References: