NCT01043484已完成2 期
Phase II Randomized Study to Compare Capecitabine + Bevacizumab Concomitantly With Radiotherapy Versus Capecitabine Concomitantly With Radiotherapy, as Neoadjuvant Treatment for Patients With Localized and Resectable Rectal Cancer
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2009年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Rate complete pathologic responses
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of the combination of capecitabine + bevacizumab concomitantly with radiotherapy versus capecitabine concomitantly with radiotherapy, as neoadjuvant treatment for patients with localized and resectable rectal cancer.
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
- •Written informed consent
- •Age ≥18 years
- •Histologically confirmed carcinoma of the rectum
- •Localized and resectable rectal cancer
- •No metastatic disease
- •Measurable disease
- •Life expectancy more than 4 months
- •Non prior treatment for rectal cancer
- •Adequate haematological function: leu ≥ 4x 109 /l, Hb ≥10 gr/dl, neutropils≥ 1,5 x 109 /l and platelets ≥100 x 109 /l
- •Adequate renal function: creatinine ≤ 106 umol/l or calculated creatinine clearance > 50 mL/min
- •Adequate liver function: AST, ALT and alkaline phosphatase ≤2.5 x UL, bilirubin ≤1.5 x UL
- •Adequate nutritional weight loss <10% of regular weight and albumin ≥ 35 g/l
排除标准
- •Unresectable rectal cancer
- •Past or current history (within the last 5 years prior to treatment start) of other malignancies.
- •Patients of childbearing potential not willing to use effective means of contraception.
- •Clinically significant cardiovascular disease
- •Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome or inability to take oral medication.
- •Patients subjected to organ allografts who require immunosuppressive treatment.
- •Severe, non-cicatrized osseous fractures, wounds or ulcers.
- •Indications of hemorrhagic diathesis or coagulopathy.
- •Severe, uncontrolled intercurrent infections or other severe, uncontrolled concomitant diseases.
- •History of unexpected severe reactions to treatment with fluoropyrimidines or known deficiency dihydropyrimidine dehydrogenase deficiency (DPD).
- •Patients subjected to a major surgical procedure, open biopsy or who have had significant traumatic lesions within the 28 days prior to beginning the treatment of the study or in whom it is foreseen that a major surgical procedure will be necessary during the course of the study; fine-needle aspiration within the 7 days prior to beginning the treatment of the study.
- •Current or recent use (within the 10 days prior to beginning the treatment of the study) of oral or parenteral anticoagulants at complete doses or thrombolytic agents. The use of low doses of warfarin is allowed, with an International Normalized Ratio [INR] of < 1.
- •Daily chronic treatment with high doses of aspirin (> 325 mg/day) or non-steroid anti-inflammatory medications (which inhibit the platelet function at doses used for treating chronic inflammatory diseases).
- •Patients who have received any drug or agent/procedure under research, i.e., who have participated in another clinical trial during the 4 weeks prior to beginning the treatment with the medications of the study
- •Any psychological, familiar conditions suggesting that the patient will not be able to complete the study
研究组 & 干预措施
A
Experimental
Bevacizumab + Capecitabine + Radiotherapy
干预措施: Bevacizumab + Capecitabine + Radiotherapy (Drug)
B
Active Comparator
Capecitabine + Radiotherapy
干预措施: Capecitabine + Radiotherapy (Drug)
结局指标
主要结局
Rate complete pathologic responses
时间窗: 17 months
次要结局
- Rate of local and distant recurrence at 3 and 5 years(78 months)
- R0 resection rate.(17 months)
- Adverse events(17 months)
- Molecular predictive markers: changes in angiogenic parameters, vascular endothelial growth factor (VEGF), vascular endothelial growth factor receptors, microvessel quantification and angiopoietin-2 (Ang-2)(17 months)
- Overall survival at 3 and 5 years(78 months)
- Rate of sphincter preservation(17 months)
- Disease free survival at 3 and 5 years(78 months)
- Rate of surgery complications(17 months)
研究者
研究点 (1)
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