Observational Study With Metronomic Oral Vinorelbine in Elderly Patients With Locally Advanced / Metastatic Non-small-cell Lung Cancer (NSCLC)

• Conditions: Locally Advanced/ Metastatic NSCLC
• Interventions: Drug: Vinorelbine

• Registration Number: NCT04208854
• Lead Sponsor: International Group of Endovascular Oncology

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.

Study Timeline

• Study Start: 2018-04-18
• Status Verified: 2019-12
• Study First Submitted: 2019-12-20
• Study First Submitted QC: 2019-12-20
• Study First Posted: 2019-12-23
• Last Update Submitted: 2019-12-23
• Last Update Posted: 2019-12-26
• Primary Completion: 2020-04-18
• Study Completion: 2020-05-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
VINORELBINA	Vinorelbine	Vinorelbine 40 mg (2 cps of 20 mg) three times a week (Monday. Wednesday, Friday), for the first 2 weeks. Starting from the third week, in the absence of any severe toxicity (≥ 3) and in the opinion of the clinician, the dosage can be increased to 50 mg (1 cps from 30 + 1 cps from 20 mg), three times a week ( Monday, Wednesday, Friday) continuously. The dosage of 40 or 50 mg is continued until progression, patient refusal or unacceptable toxicity (in the clinician's opinion).

Primary Outcome Measures

Name	Time	Method
TUMOR RESPONSE	6 MONTHS	STABLE DISEASE
number of adverse events	6 MONTHS	TOLERANCE TO VINORELBINE

Secondary Outcome Measures

Name	Time	Method
PFS	1 year	PROGRESSION FREE SURVIVAL
OS	1 YEAR	OVERALLA SURVIVAL

Trial Locations

Locations (1)

Azienda Ospedaliera Ospedali Riuniti Marche Nord; 🇮🇹 Pesaro, Yes, Italy