An Open-label Study to Assess the Effect of Combination Treatment With Avastin and Xeloda, Plus Pre-operative Standard Radiotherapy, on Response Rate in Patients With Locally Advanced Rectal Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 主要终点
- Percentage of Participants With Pathological Complete Response (pCR)
研究概览
简要总结
This open-label study will assess the efficacy and safety of Avastin (bevacizumab) plus Xeloda (capecitabine) in combination with standard technique radiotherapy of the pelvic region in the neo-adjuvant setting in patients with locally advanced primary rectal cancer. Patients will receive 4 courses of Avastin at a dose of 5 mg/kg intravenously (iv) every 2 weeks and for 38 days Xeloda at dose of 825 mg/kg twice daily orally, plus radiation therapy. After surgery, adjuvant treatment with 5-fluorouracil/leucovorin and, at the discretion of the investigator, with Avastin 5 mg/kg iv every 2 weeks for at least 6 months will be given.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Adult patients, >=18 years of age
- •Patients with confirmed rectal cancer who are subject to surgery and would benefit from pre-operative combined chemo-radiotherapy
- •Measurable and/or evaluable lesions according to RECIST criteria
- •EOCG performance status 0-1
排除标准
- •Prior radiotherapy or chemotherapy for rectal cancer
- •Untreated brain metastases or spinal cord compression or primary brain tumors
- •Chronic daily treatment with high-dose aspirin (>325 mg/day) or other medications known to predispose to gastrointestinal ulceration
- •Co-existing malignancies, or malignancies diagnosed within the last 5 years, with the exception of basal and squamous cell cancer, or cervical cancer in situ.
研究组 & 干预措施
Single Arm
干预措施: 5-fluorouracil (Drug)
Single Arm
干预措施: bevacizumab [Avastin] (Drug)
Single Arm
干预措施: capecitabine [Xeloda] (Drug)
Single Arm
干预措施: Radiation therapy (Radiation)
Single Arm
干预措施: Mesorectal excision (Procedure)
Single Arm
干预措施: leucovorin (Drug)
结局指标
主要结局
Percentage of Participants With Pathological Complete Response (pCR)
时间窗: 6 to 8 weeks following completion of neoadjuvant treatment
pCR was defined as the absence of viable tumor cells, as determined by standard histologic procedure, in the tumor specimen (including regional lymph nodes) obtained at surgery. In order to minimize evaluation bias, tumor specimens were analyzed by both a central and local pathologist. The number of participants with pathological tumor stage 0 (pT0) and regional lymph nodes stage 0 (pN0) at surgery was determined. pCR was defined as the number of participants with pT0 and pN0 at surgery divided by the total number of participants with pathological tumor stage data collected.
次要结局
- Percentage of Participants by Primary Tumor (T), Regional Lymph Nodes (N), and Distant Metastasis (M) Clinical Stage at Baseline and at the End of Neo-Adjuvant Treatment (NAT)(Baseline (BL) and end of neoadjuvant treatment (within 6 weeks after the completion of study treatment))
- Percentage of Participants Undergoing Sphincter-Saving Surgery by Type of Procedure(6 to 8 weeks after completion of study treatment)
- Percentage of Participants With Complete Response (CR) at the End of Neoadjuvant Treatment(BL and within 6 weeks after the completion of study treatment)
- Percentage of Participants With an Overall Response of CR at the End of Neoadjuvant Treatment(BL and within 6 weeks after the completion of study treatment)
- Percentage of Participants With New Lesions at the Primary Tumor Site at the End of Neoadjuvant Treatment(BL and within 6 weeks after the completion of study treatment)
- Percentage of Participants With Relapse During Follow-Up(BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 months)
- Disease-Free Survival (DFS) - Percentage of Participants With an Event(BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 months)
- DFS - Time to Event(BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until progression, up to 45 months)
- Overall Survival (OS) - Percentage of Participants With an Event(BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months)
- OS - Time to Event(BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months)
- Time to Disease Progression (TTP) - Percentage of Participants With an Event(BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months)
- TTP - Time to Event(BL, within 6 weeks after the completion of neoadjuvant treatment, every 2 weeks for 1 year following surgery, every 3 months thereafter until death, up to 45 months)