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临床试验/NCT00541112
NCT00541112终止2 期

Phase II Multicenter Study of the Impact of the Therapeutic Sequence of Radiochemotherapy (50 Gy + Capecitabine + Oxaliplatin + Cetuximab) Followed by Total Mesorectal Excision Surgery Then Post-surgery Chemotherapy (FOLFOX 4 + Cetuximab) in Synchronous Locally Advanced or Metastatic Cancers of the Rectum With Metastases Resectable From the Start (T3-4 Nx or T2 N+ M1).

UNICANCER20 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2007年10月29日最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
终止
发起方
UNICANCER
入组人数
19
试验地点
20
主要终点
Complete remission at ≥ 6 months by abdomino-pelvic-thoracic scan and a pelvic MRI

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, oxaliplatin, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving radiation therapy together with combination chemotherapy and cetuximab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy and cetuximab after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II clinical trial is studying how well giving radiation therapy together with chemotherapy and cetuximab followed by surgery, chemotherapy, and cetuximab works in treating patients with locally advanced or metastatic rectal cancer that can be removed by surgery.

详细描述

OBJECTIVES:

Primary

  • Determine the complete remission rate at 6 months after neoadjuvant radiotherapy, capecitabine, and oxaliplatin (XELOX), and cetuximab followed by surgery, adjuvant FOLFOX 4, and cetuximab in patients with synchronous locally advanced or metastatic cancer of the rectum with resectable metastases (T3-4 Nx or T2 N+ M1).

Secondary

  • Determine progression-free survival.
  • Determine overall survival.
  • Assess toxicities.
  • Evaluate objective response in patients with measurable metastases.
  • Determine the rate of local recurrence.
  • Evaluate the downstaging and downsizing of patients with operable disease.
  • Evaluate surgical complications in patients with operable disease.
  • Evaluate biological markers predictive of response to cetuximab.

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 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

结局指标

主要结局

Complete remission at ≥ 6 months by abdomino-pelvic-thoracic scan and a pelvic MRI

次要结局

  • Late radiotherapy toxicity by CTC AE v. 3.0
  • Early toxicity due to surgery (mortality at 30 days, postoperative complications, surgical recovery)
  • Sexual function
  • Sphincter function
  • Preoperative clinical response
  • Progression-free survival
  • Late toxicity
  • Overall survival
  • Early toxicity before surgery
  • Surgical complications
  • Objective response of measurable metastases by RECIST
  • Downstaging and downsizing of patients with operable disease
  • Predictive biomarkers of response to cetuximab

研究者

发起方
UNICANCER
申办方类型
Other
责任方
Sponsor

研究点 (20)

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