A Phase II Study of Capecitabine Plus Oxaliplatin in Combination With Pre-operative Pelvic Radiotherapy in Rectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Percentage of Participants With Pathological Complete Tumor Response
研究概览
简要总结
The purpose of this study is to determine the pathological complete tumor response rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Histologically confirmed locally advanced T3/T4 rectal carcinoma with or without nodal involvement requiring surgery of the primary tumor
- •Eastern Cooperative Oncology Group performance status 0-2
- •Adequate values of laboratory parameters
排除标准
- •Evidence of distant metastases
- •Previous Chemotherapy or immunotherapy for colorectal cancer
- •Previous radiotherapy to the pelvis
- •Pre-existing condition which would deter radiotherapy
- •Malignancy within last 5 years, except cured basal cell cancer of the skin and in situ cancer of the cervix
- •Clinically significant cardiac disease or myocardial infarction within the last 12 months
- •Lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome
- •Organ allografts
- •Concomitant treatment with brivudine, lamivudine, ribavirin or any other nucleoside analogues
- •Dihydropyrimidine dehydrogenase (DPD) deficiency
- •History of uncontrolled seizures, central nervous system disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for oral drug intake
研究组 & 干预措施
Capecitabine+Oxaliplatin
Eligible participants received capecitabine 1000 milligrams per square meter (mg/m^2) on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 twice a day (bid) orally, along with oxaliplatin as a 2-hour intravenous (iv) infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 gray (Gy)/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
干预措施: Capecitabine (Drug)
Capecitabine+Oxaliplatin
Eligible participants received capecitabine 1000 milligrams per square meter (mg/m^2) on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 twice a day (bid) orally, along with oxaliplatin as a 2-hour intravenous (iv) infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 gray (Gy)/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
Percentage of Participants With Pathological Complete Tumor Response
时间窗: Up to Week 16
Pathological complete tumor response was defined as grade 3 or 4 in the histological grading of regression according to Dworak classification. Grade 0 is no regression; Grade 1 is dominant tumor mass with obvious fibrosis and/or vasculopathy; Grade 2 is dominantly fibrotic changes with few tumor cells or groups; Grade 3 is defined as very few (difficult to find microscopically) tumor cells in fibrotic tissue with or without mucous substance; Grade 4 is defined as no tumor cells, only fibrotic mass (total regression or response).
次要结局
- Percentage of Participants With Downstaging of Primary Tumor and/or Lymph Nodes(From screening to Week 16)
- Percentage of Participants With Pathological Incomplete Tumor Response(Up to Week 16)
- Number of Participants With Any Adverse Events and Serious Adverse Events(Up to Week 16)
- Percentage of Participants With Resection (R0) in Participants With T4 Rectal Cancer(Up to Week 16)
- Percentage of Participants With Sphincter-preservation(Up to Week 16)
- Number of Participants With Marked Laboratory Abnormalities(Up to Week 16)