A Randomized Phase II Study of Bevacizumab, Capecitabine and Radiation Therapy With or Without Oxaliplatin in the Preoperative Treatment of Locally Advanced Rectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 9
- 主要终点
- Pathologic Response at Surgery. Overview of Complete Pathologic Responses, Good and Little Tumour Regression Rates at Surgery.
研究概览
简要总结
Phase II clinical trial, open-label, randomized, two arms, multicentre (possibly multinational). Academic, investigator initiated.
To assess the activity of bevacizumab (AvastinTM) in combination with capecitabine (XelodaTM) and radiation therapy with or without oxaliplatin (EloxatinTM) in the pre-operative treatment of locally advanced rectal cancer, followed by TME (total mesorectal excision).
详细描述
See Synopsis
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
- •Adenocarcinoma of rectum measurable (RECIST), locally advanced (defined by MRI - Tumour beyond mesorectal fascia (T4) or Tumour ≤ 2 mm from mesorectal fascia or T3 tumour < 5 cm from anal verge
- •Patient is at least 18 years of age
- •Good organ function
排除标准
- •Evidence of distant metastases
- •Contraindication for bevacizumab
- •Pregnant or breastfeeding women.
研究组 & 干预措施
AX (ARM 2)
Bevacizumab and Capecitabine concurrently with radiotherapy
干预措施: Bevacizumab (Drug)
AXE (ARM 1)
Oxaliplatin, Bevacizumab and Capecitabine concurrently with radiotherapy.
干预措施: Oxaliplatin (Drug)
AXE (ARM 1)
Oxaliplatin, Bevacizumab and Capecitabine concurrently with radiotherapy.
干预措施: Bevacizumab (Drug)
AXE (ARM 1)
Oxaliplatin, Bevacizumab and Capecitabine concurrently with radiotherapy.
干预措施: Capecitabine (Drug)
AXE (ARM 1)
Oxaliplatin, Bevacizumab and Capecitabine concurrently with radiotherapy.
干预措施: radiotherapy (Radiation)
AX (ARM 2)
Bevacizumab and Capecitabine concurrently with radiotherapy
干预措施: Capecitabine (Drug)
AX (ARM 2)
Bevacizumab and Capecitabine concurrently with radiotherapy
干预措施: radiotherapy (Radiation)
结局指标
主要结局
Pathologic Response at Surgery. Overview of Complete Pathologic Responses, Good and Little Tumour Regression Rates at Surgery.
时间窗: 4 months
Dworak tumour regression grades (TRG) were used to assess pathologic response: TRG0=no regression. TRG1=dominant tumor mass with obvious fibrosis and/or vasculopathy; TRG2=dominant fibrotic changes with few tumour cells or groups; TRG3=very few (difficult to find microscopically) tumour cells in fibrotic tissue with or without mucus substance. TRG4=no intact viable tumour cells, only fibrotic mass or presence of mucin lakes without associated malignant cells (total tumour regression). Pathologic assessments of tumour response post chemoradiotherapy as provided by investigators (read by local pathologists on operative specimens) were reviewed centrally for all pts for whom surgical materials were available (centrally reviewed set). The diagnosis of independent central reviewers primed. Pathologic complete response rates (TRG4) are reported (%). Good (TRG3 and TRG4 together) and little (TRG 0,1 and 2) tumour regression rates are summarized. For these 2 last rows, % add to 100.
次要结局
- Number of Participants With Histopathologic R0 and Negative CRM Resection(4 months)
- Number of Participants With Pathologic Complete Response at Surgery. Number of Participants With Good or Little Pathological Tumour Regression at Surgery.(4 months)
- Clinical Response Rate(3 months)
- Types and Numbers of Adverse Events - General Overview(continuous up to 1 year)
- Recurrence Rates and Disease Free Survival(up to 5 years)
- Death Rates and Overall Survival(up to 5 years)