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临床试验/NCT00227747
NCT00227747已完成3 期

Randomized Phase III Trial Comparing in a Preoperative Schedule the Result of Two Concurrent Chemoradiation Schemes (45 Gy + Capecitabine vs 50 Gy + Capecitabine - Oxaliplatin) on the Rate of Sterilization of the Operative Specimen in Resectable Rectal Carcinomas T3-4 No-2 Mo

UNICANCER68 个研究点 分布在 1 个国家目标入组 598 人开始时间: 2005年11月8日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
UNICANCER
入组人数
598
试验地点
68
主要终点
Rate of complete surgical resection

研究概览

简要总结

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving radiation therapy together with combination chemotherapy before surgery may shrink the tumor so it can be removed. It is not yet known whether giving radiation therapy together with capecitabine is more effective with or without oxaliplatin before surgery in treating rectal cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy, capecitabine, and oxaliplatin to see how well they work compared to radiation therapy and capecitabine in treating patients who are undergoing surgery for stage II or stage III rectal cancer.

详细描述

OBJECTIVES:

Primary

  • Compare the efficacy of neoadjuvant chemoradiotherapy comprising radiotherapy and capecitabine with vs without oxaliplatin followed by total mesorectal excision, in terms of the rate of complete surgical resection, in patients with resectable stage II or III rectal cancer.

Secondary

  • Compare overall and disease-free survival of patients treated with these regimens.
  • Compare clinical tumor response in patients treated with these regimens.
  • Compare acute and late toxicity of these regimens in these patients.
  • Determine biological parameters that predict tumor response and treatment-related toxicity in patients treated with these regimens.
  • Compare sphincter preservation and function in patients treated with these regimens.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Radiothérapie + Xelox

Experimental

干预措施: capecitabine (Drug)

Radiothérapie + Xelox

Experimental

干预措施: oxaliplatin (Drug)

Radiothérapie + Xelox

Experimental

干预措施: conventional surgery (Procedure)

Radiothérapie + Xelox

Experimental

干预措施: neoadjuvant therapy (Procedure)

Radiothérapie + Xelox

Experimental

干预措施: radiation therapy (Radiation)

Radiothérapie + Capécitabine

Active Comparator

干预措施: capecitabine (Drug)

Radiothérapie + Capécitabine

Active Comparator

干预措施: conventional surgery (Procedure)

Radiothérapie + Capécitabine

Active Comparator

干预措施: neoadjuvant therapy (Procedure)

Radiothérapie + Capécitabine

Active Comparator

干预措施: radiation therapy (Radiation)

结局指标

主要结局

Rate of complete surgical resection

次要结局

  • Overall survival
  • Disease-free survival
  • Sphincter preservation
  • Sphincter function
  • Biological parameters that predict tumor response and treatment-related toxicity
  • Acute and late toxicity

研究者

发起方
UNICANCER
申办方类型
Other
责任方
Sponsor

研究点 (68)

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