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

NCT ID: NCT04208854

Last Updated: 2019-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-18

Study Completion Date

2020-05-18

Brief Summary

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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

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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

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Locally Advanced/ Metastatic NSCLC

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

Vinorelbine

Intervention Type 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).

Interventions

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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).

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Sanitaria Ospedaliera

OTHER

Sponsor Role collaborator

International Group of Endovascular Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Azienda Ospedaliera Ospedali Riuniti Marche Nord

Pesaro, Yes, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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DAVID ROSSI, MD

Role: CONTACT

Phone: +390721364093

Email: [email protected]

Facility Contacts

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David Rossi

Role: primary

Other Identifiers

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VINORELBINA

Identifier Type: -

Identifier Source: org_study_id