Study of Patient Preference for Oral or Intravenous Vinorelbine in the Treatment of Advanced NSCLC
Status:
Completed
Trial end date:
2018-05-01
Target enrollment:
Participant gender:
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
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).
Phase:
Phase 4
Details
Lead Sponsor:
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori