An International Multicentre Open Label Randomised Phase II Advanced Anal Cancer Trial Comparing Cisplatin Plus 5 FU vs Carboplatin Plus Weekly Paclitaxel in Patients With Inoperable Locally Recurrent or Metastatic Disease
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Best overall response rate by 24 weeks post treatment
研究概览
简要总结
Anal cancer is a relatively uncommon disease and there is currently no standard chemotherapy treatment for patients with inoperable locally recurrent or metastatic disease. The aim of this phase II study is compare two well known and largely used chemotherapy regimens - Cisplatin plus 5-fluorouracil vs Carboplatin plus Paclitaxel. The result of this study will set a standard of care for this disease and provide useful information for future Phase III trials.
详细描述
Study design: This is an international, multicentre, open label, randomised phase II trial. Patients will be randomised to receive either cisplatin plus 5-FU or carboplatin plus weekly paclitaxel. Region (Europe, North America, South America & Australia), (Eastern Cooperative Oncology Group- ECOG) ECOG performance status (PS) (0-1 vs. 2), HIV status (positive vs. negative) and extent of disease (locally recurrent vs. metastatic) will be used as stratification factors. Overall response rate is the primary endpoint.
Indication: First line treatment of patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anus.
Length of study: Recruitment should be completed within 3 years. The estimated recruitment rate is between 4-6 patients per month once it is established at multiple centres.
Primary Objective: To evaluate best overall response rate by 24 weeks post treatment in the cisplatin plus 5-fluorouracil arm versus the carboplatin plus weekly paclitaxel arm
Secondary Objectives: To evaluate: - Progression-free survival - Overall survival - Disease control rate (stable disease or better) at 12 and 24 weeks - Best overall response of metastatic lesions - Toxicity (graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Version 4) - Quality of Life (using EORTC QLQ-C30 version 3 and EQ-5D-5L questionnaires).
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm A
Cisplatin and 5-Fluorouracil
干预措施: Cisplatin (Drug)
Arm A
Cisplatin and 5-Fluorouracil
干预措施: 5-Fluorouracil (5-FU) (Drug)
Arm B
Carboplatin plus Paclitaxel
干预措施: Carboplatin (Drug)
Arm B
Carboplatin plus Paclitaxel
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Best overall response rate by 24 weeks post treatment
时间窗: 24 weeks
Best overall response rate is defined as the percentage of patients achieving confirmed partial or complete responses as per RECIST v1.1 by 24 weeks post treatment start in the intention to treat population. Sensitivity analyse will also be performed.
次要结局
- Feasibility of conducting a multicentre, international study on squamous cell carcinoma of the anus and recruiting within a reasonable time frame.(3 years)
- Toxicity(Toxicity will be analysed once all patients have been followed up for at least 4 weeks post treatment.)
- Progression-free survival(PFS will be analysed once all patients have been followed up for at least 12 months post treatment.)
- Overall survival(Overall survival will be analysed once all patients have been followed up for at least 12 months post treatment.)
- Disease control rate(12 and 24 weeks post treatment start)
- Best overall response rate of non-irradiated lesions(24 weeks post treatment start)
- Anti-tumour activity and magnitude of tumour response(24 weeks)
- Quality of Life(3 years)
- Identification of potential tumour biomarker(3 years)