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临床试验/NCT01186081
NCT01186081已完成3 期

Comparison of Preoperative and Postoperative Radiotherapy and Capecitabine in Locally Advanced Rectal Cancer

Asan Medical Center2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2004年3月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
240
试验地点
2
主要终点
Disease-free survival

研究概览

简要总结

Based on the potential advantaged of preoperative chemoradiotherapy and oral fluoropyrimidine, the investigators planned a prospective randomized phase III trial which compares preoperative chemoradiotherapy and postoperative chemoradiotherapy with conventional radiation schedule and oral fluoropyrimidine to establish new standard neo-adjuvant therapy regimen in locally advanced rectal cancer.

详细描述

Although there have been no confirmative data which favored preoperative chemoradiotherapy, preoperative chemoradiation have many theoretical advantage compared with postoperative one. Preoperative radiotherapy with intensive short course regimen showed significant improvement in local control even with TME, but there has been no large prospective randomized trial which proved the efficacy of preoperative chemoradiotherapy compared with the standard postoperative chemoradiotherapy. Although the final result of the German Trial may give the answer for this question, there has been no randomized controlled trial which investigated the efficacy of preoperative chemoradiotherapy using oral fluoropyrimidine which have many theoretical and clinical advantages mentioned above; the German Trial used 5-day continuous infusion of 5-FU. The investigators think that preoperative chemoradiotherapy with oral capecitabine could be new standard regimen in locally advanced rectal cancer, but this regimen must be compared with the standard postoperative chemoradiotherapy through well designed prospective randomized trial. Based on the potential advantaged of preoperative chemoradiotherapy and oral fluoropyrimidine, the investigators planned prospective randomized phase III trial which compares preoperative chemoradiotherapy and postoperative chemoradiotherapy with conventional radiation schedule and oral fluoropyrimidine to establish new standard neo-adjuvant therapy regimen in locally advanced 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
19 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Histologically confirmed rectal adenocarcinoma
  • Tumor located below 10 cm from the anal verge
  • Clinical stage T3 or potentially resectable T4, or N+ on endorectal ultrasonography (EUS) and computed tomography (CT)
  • Patients must be > 18 years and < 76 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Adequate bone marrow reserve
  • Adequate renal function
  • Adequate liver function
  • Signed informed consent prior to randomization

排除标准

  • Evidence of distant metastasis
  • Previous history of chemotherapy or radiotherapy
  • History of malignancy during recent 5 years other than skin cancer
  • Pregnant or lactating woman
  • Familial history of colorectal cancer

结局指标

主要结局

Disease-free survival

时间窗: Three year

次要结局

  • Overall survival(Three year)
  • Local relapse-free survival(Three year)
  • Sphincter preservation rate(Three year)
  • Treatment related toxicities(Three year)

研究者

申办方类型
Other

研究点 (2)

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