Randomized Cross-over Study of Patient Preference for Oral or Intravenous Vinorelbine in the Treatment of Advanced NSCLC. A Phase IV Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 8
- 主要终点
- Patients preference for IV or PO vinorelbine.
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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.
- •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);
研究组 & 干预措施
Arm A
•Arm A: first cycle of IV vinorelbine (30 mg/m2) and second cycle of PO vinorelbine (60mg/m2)
干预措施: Vinorelbine (Drug)
Arm B
• Arm B: first cycle with PO vinorelbine (60mg/m2) followed by a second cycle of IV vinorelbine (30mg/m2)
干预措施: Vinorelbine (Drug)
结局指标
主要结局
Patients preference for IV or PO vinorelbine.
时间窗: 2 years
At the time of patient preference, a questionnaire will be filled in by patients.
次要结局
- Progression-free survival (PFS)(2 years)
- Overall response rate (RR)(2 years)
- Overall survival (OS)(2 years)
- Toxicity of both drug formulations(2 years)
- Subjective reasons for treatment choice(2 years)