Statement: Patients in the control group of the primary trial had a median Overall Survival of less than a year, however several patients in arm B survived longer than a year.
Primary_evidence: Outcome Measurement:    Overall Survival   The main endpoint of this study is overall survival defined as the time from randomisation to the date of death or last follow-up. For patients who have not died, survival duration will be censored at the date of last contact or last follow-up or the date of last news.   Time frame: From baseline up to 3 years 1 month Results 1:    Arm/Group Title: Vinflunine   Arm/Group Description: Patients randomised in the test arm (arm A) received VFL at the dose of 280 mg/m  on day 1 of each cycle every 3 weeks, over a 20-minute intravenous (IV) infusion. Cycles were repeated every 3 weeks.   vinflunine: 280 mg/m2 on day 1 of each cycle every 3 weeks   Overall Number of Participants Analyzed: 298   Median (95% Confidence Interval)   Unit of Measure: Months  9.1        (7.7 to 10.4) Results 2:    Arm/Group Title: Alkylating Agent   Arm/Group Description: Patients randomised in the control arm (arm B) received an alkylating agent used as a single agent which was available in the investigational center and was approved for the treatment of cancer in the country.   Alkylating agent of physician choice registered in cancer: cyclophosphamide or melphalan or mitomycin C or thiotepa or cisplatin or carboplatin   Overall Number of Participants Analyzed: 296   Median (95% Confidence Interval)   Unit of Measure: Months  9.3        (7.5 to 10.9)