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

NCT04208854 | Unknown

• 1 other identifier: VINORELBINA
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced/ Metastatic NSCLC

Outcome Measures

Primary Outcomes (2)

• TUMOR RESPONSE

  STABLE DISEASE

  6 MONTHS

• number of adverse events

  TOLERANCE TO VINORELBINE

  6 MONTHS

Secondary Outcomes (2)

• PFS

  1 year

• OS

  1 YEAR

Study Arms (1)

VINORELBINA

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).

Drug: Vinorelbine

Interventions

Vinorelbine DRUG

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).

VINORELBINA

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

ELDERLY PATIENTS \<70 YEARS OLD

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• International Group of Endovascular Oncology: lead
• Azienda Sanitaria Ospedaliera: collaborator

Study Sites (1)

Azienda Ospedaliera Ospedali Riuniti Marche Nord

Pesaro, Yes, 61122, Italy

RECRUITING

MeSH Terms

Interventions

Vinorelbine

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Central Study Contacts

DAVID ROSSI, MD

CONTACT

+390721364093; david.rossi@ospedalimarchenord.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: December 23, 2019
• Study Start: April 18, 2018
• Primary Completion: April 18, 2020
• Study Completion: May 18, 2020
• Last Updated: December 26, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)