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

Sponsor
International Group of Endovascular Oncology
Study ID
NCT04208854
Status
Unknown

Conditions

  • Locally Advanced/ Metastatic NSCLC

Eligibility Criteria

Sex
ALL
Age
70 Years - N/A
Healthy Volunteers
Not accepted

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).

Study Details

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.

Key Dates

Start date
Apr 18, 2018
Status verified
Dec 2019
Primary completion
Apr 18, 2020
Completion
May 18, 2020

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: 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).

Primary Outcome Measure

TUMOR RESPONSE [ Time Frame: 6 MONTHS ]

Central Contacts