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临床试验/EUCTR2005-003463-23-ES
EUCTR2005-003463-23-ES进行中(未招募)1 期

ADJUVANT TREATMENT OF FULLY RESECTED STAGE III COLON CANCER WITH FOLFOX-4 VERSUS FOLFOX-4 PLUS CETUXIMAB Tratamiento adyuvante con FOLFOX-4 versus FOLFOX-4 + cetuximab para el cáncer de colon en estadio III extirpado completamente - PETACC 8

Fédération Francophone de Cancérologie Digestive (FFCD)0 个研究点目标入组 2,000 人开始时间: 2006年2月16日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
2,000

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • - Age > or = 18 and <75 years
  • - Pathologically confirmed stage III adenocarcinoma of the colon, regardless of EGFR status,
  • - Curative R0 resection performed between 28 and 56 days prior to randomization
  • - No prior chemotherapy
  • - No prior abdominal or pelvic irradiation
  • - WHO performance status: 0 or 1
  • - Signed written informed consent obtained prior to any study specific screening procedures
  • - Patients with childbearing potential should use effective contraception
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • - Distant metastatic disease
  • - Inflammatory bowel disease
  • - Rectal cancer located within 15 cm from the anal verge by endoscopy or above the peritoneal reflection at surgery or having received radiation therapy prior to surgery
  • - Pregnant or breast-feeding woman
  • - Neuropathy
  • - Known hypersensitivity reaction to any of the components of study treatments.

研究者

发起方
Fédération Francophone de Cancérologie Digestive (FFCD)

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