Non-small Cell Lung Cancer MetastaticPhase 4VIVOSNCT01848613
Study of Patient Preference for Oral or Intravenous Vinorelbine in the Treatment of Advanced NSCLC
A Phase 4 study testing Vinorelbine in people with Non-small Cell Lung Cancer Metastatic, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 8 sites in Italy.
Trial summary
Title: Randomized cross-over study of patient preference for oral or intravenous vinorelbine in the treatment of advanced NSCLC. A phase IV study. ShortTitle/ Acronym: VIVOS Protocol Code :IRST162.05 Study Design: Randomized, open label cross-over study Study Duration: Two years Study Center(s): Multicenter study… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer Metastatic
- What is being tested?
- Vinorelbine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 8 sitesItaly
- Study dates
- Oct 2012to May 2018
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed stage IIIB or IV NSCLC.
- Age ≥ 70 and Eastern Cooperative Oncology Group (ECOG) Performance status ≤2 or age ≤ 70 but ECOG PS ≥ 2
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan. See section 9.2 and Appendix E for the evaluation of measurable disease.
- Patients with asymptomatic brain metastases are eligible
- Patients with recurrent disease after previous surgery are eligible
- Life expectancy > 3 months
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- Patients must have normal organ and marrow function
- Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- The participant may not enter the study if ANY of the following apply:
- Patients who have had previous chemotherapy for lung cancer or radiotherapy on target lesions.
- Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
- Presence of infection.
- Preexisting clinically significant peripheral neuropathy.
- History or evidence of malabsorption syndrome or disease that may significantly affect gastrointestinal function.
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- Patients with known symptomatic uncontrolled brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to vinorelbine or other agents used in the study.
- Presence of medical problems of sufficient severity to prevent full compliance with the study.
- Other known malignant neoplastic diseases in the patient's medical history with a disease-free interval of less than 5 years (except for previously treated basal cell carcinoma and in situ carcinoma of the uterine cervix);
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Italy8 sites
U.O. Oncologia Medica ULSS 1 Belluno
Belluno, 32100
U.O. Oncologia Ospedale Cervesi
Cattolica, RN, 47841
U.O. Oncologia Ospedale Civile degli Infermi
Faenza, RA, 48018
U.O. Oncologia Ospedale Civile Umberto I
Lugo, RA, 48022
Irccs Irst
Meldola (FC), FC, 47014
U.O. Oncologia ed Ematologia Oncologica ULSS 13 MIRANO
Mirano, VE, 30035
UO Oncologia Medica, Ospedale S.Maria delle Croci
Ravenna, RA, 48121
U.O. Oncologia Ospedale degli Infermi
Rimini
About this study
Official title: Randomized Cross-over Study of Patient Preference for Oral or Intravenous Vinorelbine in the Treatment of Advanced NSCLC. A Phase IV Study.
Title: Randomized cross-over study of patient preference for oral or intravenous vinorelbine in the treatment of advanced NSCLC. A phase IV study.
ShortTitle/ Acronym: VIVOS
Read more
Protocol Code :IRST162.05
Study Design: Randomized, open label cross-over study
Study Duration: Two years
Study Center(s): Multicenter study
Objectives:
Primary: Patient preference for oral or intravenous vinorelbine Secondary: Overall Response Rate, Time to Progression, Toxicity, Survival, Subjective reasons for treatment choice.
Number of Subjects: 120
Diagnosis and Main Inclusion Criteria:
Patients affected by stage IIIB or stage IV NSCLC candidates to receive a first line chemotherapy with vinorelbine due to age ≥ 70 and Eastern Cooperative Oncology Group (ECOG) Performance status ≤2 or age ≤ 70 but ECOG PS ≥ 2
Study Product, Dose, Route, Regimen and duration of administration :
- Arm A: first cycle of IV vinorelbine (30 mg/m2) and second cycle of PO vinorelbine (60mg/m2)
- Arm B: first cycle with PO vinorelbine (60mg/m2) followed by a second cycle of IV vinorelbine (30mg/m2) In both arms vinorelbine will be given at day 1 and day 8 every 3 weeks. From the third cycle onwards patients will have to choose to receive oral or intravenous vinorelbine. Vinorelbine capsules will be administered at the dosage of 60 mg/m2 for the first course and then may be increased to 80 mg/m² at physician's choice.
Treatment will be repeated every 21 days and continued until disease progression, intolerable toxicity or patient refusal.
Reference therapy: Vinorelbine 30 mg/m2 intravenous day 1 and 8 every 21 days
Statistical Methodology: The sample size is calculated based on 75% of patients preferring "oral" vinorelbine and 25% preferring "intravenous" vinorelbine. Therefore, the investigators would compare patients preferring "oral" vinorelbine as 75% compared to a null hypothesis of 50% (no difference in proportion of patients preferring "oral" to "intravenous"). With 80% power and a total alpha of 0.05, the estimated sample size is 60 for group (120 total). During recruitment period, a formal interim analysis was planned when 60 patients (30 for group) have been enrolled, with a p-value <0.0001. To claim statistical significance in the final analysis, the overall p-value is still 5% (referred to Peto-Haybittle rule).
- Conditions
- Non-small Cell Lung Cancer Metastatic
- Being tested
- Vinorelbine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VinorelbineDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | •Arm A: first cycle of IV vinorelbine (30 mg/m2) and second cycle of PO vinorelbine (60mg/m2) Receives: Drug: Vinorelbine |
| Arm B | Experimental | • Arm B: first cycle with PO vinorelbine (60mg/m2) followed by a second cycle of IV vinorelbine (30mg/m2) Receives: Drug: Vinorelbine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients preference for IV or PO vinorelbine.
At the time of patient preference, a questionnaire will be filled in by patients.
Measured: 2 years
Secondary outcomes (5)
Overall response rate (RR)
Measured: 2 years
Progression-free survival (PFS)
Measured: 2 years
Overall survival (OS)
Measured: 2 years
Toxicity of both drug formulations
Measured: 2 years
Subjective reasons for treatment choice
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2013 (estimated)
- Study startOct 2012
- Primary completionOct 2016
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer MetastaticStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudio Dazzi, MD, Study chair, UO Oncologia Medica, Ospedale S.Maria delle Croci, RAVENNA - ITALY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01848613
- Sponsor's protocol ID
- IRST162.05
- Other IDs
- 2012-003544-68
- Acronym
- VIVOS
- Status last verified
- Nov 2018
- First submitted
- 26 Apr 2013
- Last updated
- 9 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Cross-over Study of Patient Preference for Oral or Intravenous Vinorelbine in the Treatment of Advanced NSCLC. A Phase IV Study.
- ClinicalTrials.gov ID
- NCT01848613
- Acronym / sponsor ID
- VIVOS / IRST162.05
- Conditions
- Non-small Cell Lung Cancer Metastatic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
- Study start
- Oct 2012 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 7 May 2013 (estimated)
- 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.
Title: Randomized cross-over study of patient preference for oral or intravenous vinorelbine in the treatment of advanced NSCLC. A phase IV study.
ShortTitle/ Acronym: VIVOS
Protocol Code :IRST162.05
Study Design: Randomized, open label cross-over study
Study Duration: Two years
Study Center(s): Multicenter study
Objectives:
Primary: Patient preference for oral or intravenous vinorelbine Secondary: Overall Response Rate, Time to Progression, Toxicity, Survival, Subjective reasons for treatment choice.
Number of Subjects: 120
Diagnosis and Main Inclusion Criteria:
Patients affected by stage IIIB or stage IV NSCLC candidates to receive a first line chemotherapy with vinorelbine due to age ≥ 70 and Eastern Cooperative Oncology Group (ECOG) Performance status ≤2 or age ≤ 70 but ECOG PS ≥ 2
Study Product, Dose, Route, Regimen and duration of administration :
- Arm A: first cycle of IV vinorelbine (30 mg/m2) and second cycle of PO vinorelbine (60mg/m2)
- Arm B: first cycle with PO vinorelbine (60mg/m2) followed by a second cycle of IV vinorelbine (30mg/m2) In both arms vinorelbine will be given at day 1 and day 8 every 3 weeks. From the third cycle onwards patients will have to choose to receive oral or intravenous vinorelbine. Vinorelbine capsules will be administered at the dosage of 60 mg/m2 for the first course and then may be increased to 80 mg/m² at physician's choice.
Treatment will be repeated every 21 days and continued until disease progression, intolerable toxicity or patient refusal.
Reference therapy: Vinorelbine 30 mg/m2 intravenous day 1 and 8 every 21 days
Statistical Methodology: The sample size is calculated based on 75% of patients preferring "oral" vinorelbine and 25% preferring "intravenous" vinorelbine. Therefore, the investigators would compare patients preferring "oral" vinorelbine as 75% compared to a null hypothesis of 50% (no difference in proportion of patients preferring "oral" to "intravenous"). With 80% power and a total alpha of 0.05, the estimated sample size is 60 for group (120 total). During recruitment period, a formal interim analysis was planned when 60 patients (30 for group) have been enrolled, with a p-value <0.0001. To claim statistical significance in the final analysis, the overall p-value is still 5% (referred to Peto-Haybittle rule).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Vinorelbine•Arm A: first cycle of IV vinorelbine (30 mg/m2) and second cycle of PO vinorelbine (60mg/m2) |
| Arm B | Experimental | Drug: Vinorelbine• Arm B: first cycle with PO vinorelbine (60mg/m2) followed by a second cycle of IV vinorelbine (30mg/m2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically or cytologically confirmed stage IIIB or IV NSCLC.
- Age ≥ 70 and Eastern Cooperative Oncology Group (ECOG) Performance status ≤2 or age ≤ 70 but ECOG PS ≥ 2
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan. See section 9.2 and Appendix E for the evaluation of measurable disease.
- Patients with asymptomatic brain metastases are eligible
- Patients with recurrent disease after previous surgery are eligible
Key exclusion criteria (10 listed)
- Patients who have had previous chemotherapy for lung cancer or radiotherapy on target lesions.
- Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
- Presence of infection.
- Preexisting clinically significant peripheral neuropathy.
- History or evidence of malabsorption syndrome or disease that may significantly affect gastrointestinal function.
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 |
|---|---|---|
| Vinorelbine | Drug | Arm A, Arm B |
Primary outcome
Patients preference for IV or PO vinorelbine.
Time frame: 2 years
At the time of patient preference, a questionnaire will be filled in by patients.
5 secondary outcomes
Overall response rate (RR)
Time frame: 2 years
Progression-free survival (PFS)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Toxicity of both drug formulations
Time frame: 2 years
Subjective reasons for treatment choice
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2018.
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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.
Claudio Dazzi, MD study chair
UO Oncologia Medica, Ospedale S.Maria delle Croci, RAVENNA - ITALY
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vinorelbine in people with Non-small Cell Lung Cancer Metastatic, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 8 sites 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 9 inclusion and 10 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: finished, as of the sponsor's last update on 9 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients preference for IV or PO vinorelbine. (time frame: 2 years). 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 9 Nov 2018.