A Multicenter Phase 4 Geriatric Assessment Directed Trial to Evaluate Gemcitabine +/- Nab-paclitaxel in Elderly Pancreatic Cancer Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Barthel's ADL [Barthel's scale in activities of daily living]
研究概览
简要总结
The GrantPax study is a multicenter phase 4 geriatric assessment directed trial to evaluate gemcitabine +/- nab-paclitaxel in elderly pancreatic cancer patients. The primary objective is that CGA-stratified patients do not decline in their CGA performance in response to chemotherapy measured as a loss of five points or less in the Barthel's ADL, (ADL1 vs. ADL2 during core CGA assessment).
详细描述
The hypothesis of the proposed study is that individualized assessment directed treatment algorithms identifies elderly patients, who benefit from combined nab-paclitaxel/gemcitabine therapy. The project uses a CGA, which includes various tests and scoring systems, to stratify patients as "GO-GO", "SLOW-GO" or "FRAIL" patients. Depending on test results patients receive chemotherapy (GO-GO group: nab-paclitaxel/gemcitabine; SLOW-GO group: gemcitabine monotherapy) or best supportive care (FRAIL group). After the first cycle of chemotherapy (4 weeks) a subsequent CGA and a safety assessment will be performed to assign patients to their definite treatment arm. The primary objective is that CGA-stratified patients do not decline in their CGA performance in response to chemotherapy measured as a loss of five points or less in the Barthel's ADL (ADL1 vs. ADL2 during core CGA assessment).
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
- 70 Years 至 —（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
GO-GO arm
Nab-paclitaxel 125 mg/m^2 i.v. over 30 minutes followed by gemcitabine infusion 1000 mg/m^2 on days D1, D8, D15 of a 28-day cycle.
干预措施: Nab-paclitaxel (Drug)
GO-GO arm
Nab-paclitaxel 125 mg/m^2 i.v. over 30 minutes followed by gemcitabine infusion 1000 mg/m^2 on days D1, D8, D15 of a 28-day cycle.
干预措施: Gemcitabine (Drug)
SLOW-GO arm
Gemcitabine 1000 mg/m^2 i.v. on days D1, D8, D15 of a 28-day cycle.
干预措施: Gemcitabine (Drug)
FRAIL arm
Best supportive care as determined by the investigator.
干预措施: Best Supportive Care (Other)
结局指标
主要结局
Barthel's ADL [Barthel's scale in activities of daily living]
时间窗: 4 weeks
Loss of five points or less in the Activity of Daily Living (Barthel's ADL; assessed during 2nd CGA) after first cycle of chemotherapy (or after 4 weeks in BSC group) compared to the initial ADL for each treatment groups.
次要结局
- ADL (Barthel) [Activities of Daily Living](4 weeks)
- IADL (Lawton/Browdy) [Instrumental Activities of Daily Living](4 weeks)
- G8-Questionnaire(4 weeks)
- Percentage of patients receiving at least one chemotherapy in each treatment group(12 months)
- Duration of treatment(12 months)
- Cumulative dose(12 months)
- QoL [Quality of Life](12 months)
- Discrepancy between CGA strata estimation by the investigator and true CGA assessment(12 months)
- ECOG [Eastern Cooperative Oncology Group](4 weeks)
- AEs/SAEs [Adverse Events/Serious Adverse Events](12 months)
- PFS [Progression Free Survival](12 months)
- OS [Overall Survival](12 months)
- CR [Complete Response](12 months)
- DCR [Disease Control Rate](12 months)
- PR [Partial Response](12 months)
- ORR [Objective Response Rate](12 months)
- Percentage of patients escalating treatment(12 months)
- CGA [Comprehensive Geriatric Assessment](4 weeks)