Additional Chemotherapy After Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Rectal Cancer
A Phase II Study of Additional Four-week Chemotherapy With Capecitabine During the Resting Periods After Six-week Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Rectal Cancer
研究概览
地位
条件
详细说明
Neoadjuvant chemoradiotherapy (NCRT) has been used as standard treatment modality in patients with locally advanced rectal cancer (LARC) because of increased local control, enhanced sphincter preservation, and less toxicity.NCRT has enhanced down-staging of tumor and reduced local recurrence. However, survival benefit of NCRT has not been demonstrated and the rate of distant metastasis was still reported as high as 30%.
Patients with pathologic complete remission (pCR) after NCRT have shown excellent survival benefit. We inferred that additional chemotherapy during the resting period could enhance the pCR rate. The aim of the present study is to evaluate the safety and efficacy of an additional 4-week chemotherapy with capecitabine after the conventional 6-week NCRT in patients with LARC.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Daejeon、大韩民国、301-721
- Chungnam National University Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- histologically proven, locally advanced adenocarcinoma of the rectum
- an Eastern Cooperative Oncology Group (ECOG) score of 0-2
- adequate function of major organs
- a signed informed consent.
Exclusion Criteria:
- other co-existing malignancy or malignancy within the last 5 years prior to enrollment
- severe concurrent medical or psychiatric disorders
- prior RT to pelvis
- pregnant or lactating patients
学习计划
研究是如何设计的？
设计细节
合作者和调查者
调查人员
- 首席研究员：Ji Yeon Kim, MD., PhD、Surgical Oncology Research Lab
研究记录日期
研究主要日期
学习开始
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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