Evaluation of Bevacizumab in Combination With First-Line Chemotherapy in Patients Aged 75 Years of Older With Metastatic Colorectal Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Initial examination
研究概览
简要总结
To evaluate tolerance to and efficacy of bevacizumab in the treatment of MCRC in elderly patients, we propose a phase II randomised study comparing a chemotherapy + bevacizumab arm with a chemotherapy alone arm in the first-line treatment of MCRC in patients aged 75 years and older.
This study is destined to continue as a phase III trial if both arms meet the selection criteria to show or not the benefits of treatment with bevacizumab combined with chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 75 years or older
- •histologically proven unresectable metastatic colorectal adenocarcinoma
- •Measurable lesion according to RECIST criteria
- •Absence of prior chemotherapy for metastatic disease. Adjuvant chemotherapy following resection of the primary tumor is authorized if completed more than 6 months previously
- •Patients treated with anticoagulants (coumadin, warfarin) can be included if close surveillance of the INR can be ensured. A change to low-molecular-weight heparin is preferable as long as the indications are respected
- •Completed geriatric self-questionnaire
- •Completed "Team" geriatric questionnaire (including Spitzer QoL Index)
- •Written informed consent
排除标准
- •Estimated life expectancy < 3 months
- •Non-resolved intestinal occlusion or sub-occlusion
- •Cerebral metastasis
- •Other evolutive malignant tumor (non-stabilized cancer for less than 2 years)
- •Evolutive gastroduodenal ulcer, wound or bone fracture
- •Active heart disease: uncontrolled hypertension, myocardial infarction In the previous 6 months, angina, non-compensated congestive heart failure
- •Major surgery, except for biopsy, or irradiation in the 4 weeks preceding the start of treatment
- •Polynuclear neutrophils <1500/mm3, platelets <100 000/mm3 or 24-h proteinuria > 1g
- •History of arterial thromboembolic event (cerebrovascular accident, transient ischemic attack, subarachnoid hemorrhage) in the 12 months preceding the first dose of bevacizumab
- •History of distal or visceral ischemia ≥ grade 2 in the 12 months preceding the first dose of bevacizumab
- •History of life-threatening pulmonary embolism in the 6 months preceding the first dose of bevacizumab
- •Impossibility to ensure regular follow-up
研究组 & 干预措施
chimiotherapy alone
- LV5FU2 simplified,
- 5-fluorouracil/leucovorin with oxaliplatin 4 (FOLFOX) simplified,
- fluorouracil, leucovorin, and irinotecan(FOLFIRI) modified.
干预措施: LV5FU2 simplified, FOLFOX 4 simplified, FOLFIRI modified (Drug)
chemiotherapy + bevacizumab 5 mg/kg/ 2 weeks
- LV5FU2 simplified,
- FOLFOX 4 simplified,
- FOLFIRI modified.
- Bevacizumab 5 mg/kg/ 2 weeks
干预措施: LV5FU2 simplified,FOLFOX 4 simplified, FOLFIRI modified, Bevacizumab 5 mg/kg/ 2 weeks (Drug)
结局指标
主要结局
Initial examination
时间窗: 21 days before the first course of treatment
thoraco-abdomino-pelvic tomodensitometry or thoracic tomodensitometry and abdomino-pelvic MRI with identification and measurement of the target tumors according to RECIST (Response Evaluation Criteria in Solid Tumors )criteria.
次要结局
- Initial examination(14 days before inclusion)