Locally Advanced/ Metastatic NSCLCVINORELBINANCT04208854
Observational Study With Metronomic Oral Vinorelbine in Elderly Patients With Locally Advanced / Metastatic Non-small-cell Lung Cancer (NSCLC)
An observational study of Locally Advanced/ Metastatic NSCLC, run by International Group of Endovascular Oncology at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Locally Advanced/ Metastatic NSCLC
- What is being tested?
- Vinorelbine
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 18 Apr 2018to 18 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Older adult
Study population: ELDERLY PATIENTS <70 YEARS OLD
Who may be able to join
- 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
Who cannot join
- Gastrointestinal disorders that contraindicate the intake of the capsules (type ulcerative colitis or Chron's disease).
- Performance Status ECOG ≥ 3
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliera Ospedali Riuniti Marche Nord
Pesaro, Yes, 61122
David Rossi, 0721364093, david.rossi@ospedalimarchenord.it
David Rossi, MD
About this study
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.
Read the 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.
- Conditions
- Locally Advanced/ Metastatic NSCLC
- Being tested
- Vinorelbine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VinorelbineDrug
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 group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Vinorelbine |
What is being measured
The primary outcome is the main question the study is designed to answer.
TUMOR RESPONSE
STABLE DISEASE
Measured: 6 MONTHS
number of adverse events
TOLERANCE TO VINORELBINE
Measured: 6 MONTHS
Secondary outcomes (2)
PFS
PROGRESSION FREE SURVIVAL
Measured: 1 year
OS
OVERALLA SURVIVAL
Measured: 1 YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start18 Apr 2018
- Primary completion18 Apr 2020 (estimated)
- Study completion18 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced/ Metastatic NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Group of Endovascular Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Sanitaria Ospedaliera
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04208854
- Sponsor's protocol ID
- VINORELBINA
- Acronym
- VINORELBINA
- Status last verified
- Dec 2019
- First submitted
- 20 Dec 2019
- Last updated
- 26 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study With Metronomic Oral Vinorelbine in Elderly Patients With Locally Advanced / Metastatic Non-small-cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT04208854
- Acronym / sponsor ID
- VINORELBINA / VINORELBINA
- Conditions
- Locally Advanced/ Metastatic NSCLC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- International Group of Endovascular OncologyUniversity, hospital or other
- Collaborators
- Azienda Sanitaria Ospedaliera
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- 18 Apr 2020 (estimated)
- Study completion
- 18 May 2020 (estimated)
- First posted
- 23 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VINORELBINA | – | Drug: VinorelbineVinorelbine 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). |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- ELDERLY PATIENTS <70 YEARS OLD
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Gastrointestinal disorders that contraindicate the intake of the capsules (type ulcerative colitis or Chron's disease).
- Performance Status ECOG ≥ 3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VinorelbineVinorelbine 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 | VINORELBINA |
Primary outcome
TUMOR RESPONSE
Time frame: 6 MONTHS
STABLE DISEASE
number of adverse events
Time frame: 6 MONTHS
TOLERANCE TO VINORELBINE
2 secondary outcomes
PFS
Time frame: 1 year
OS
Time frame: 1 YEAR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced/ Metastatic NSCLC, run by International Group of Endovascular Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DAVID ROSSI, MD (+390721364093, david.rossi@ospedalimarchenord.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TUMOR RESPONSE (time frame: 6 MONTHS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2019.