NCT02404935已完成2 期
Randomized Phase II Study of First-line FOLFIRI Plus Cetuximab for 8 Cycles Followed by Either Single-agent Cetuximab as Maintenance Therapy or Observation in Patients With Wild-type KRAS and NRAS Metastatic Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UNICANCER
- 入组人数
- 139
- 试验地点
- 46
- 主要终点
- Progression Free Survival at 6 months
研究概览
简要总结
National multicentric phase II trial evaluating whether single agent cetuximab is effective as maintenance therapy after 8 cycles of first line FOLFIRI plus cetuximab in mCRC patients with KRAS and NRAS wild-type genes, assessed by progression-free survival at 6 months after start of maintenance therapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed colorectal cancer
- •KRAS and NRAS wild-type genes after analysis of mutation status from the primary tumour or metastasis
- •Non resectable metastatic disease in a curative intent
- •No prior chemotherapy except for fluoropyrimidines with or without oxaliplatin-based adjuvant treatment, at least 6 months before inclusion
- •At least one measurable tumour target (higher than 20 mm) according to RECIST criteria, which has never been irradiated
- •Life expectancy above 3 months
- •Performance Status ≤2 (WHO)
- •Patient ≥18 years-old
- •Acceptable blood test
- •Patient having signed a written informed consent form
排除标准
- •Known and/or symptomatic brain metastases
- •Known allergy to one of treatment components
- •Neurological or psychiatric condition which could interfere with good treatment compliance
- •Current anti-tumour treatment : chemotherapy or targeted therapy or radiotherapy ≤ 14 days before randomisation
- •Other severe conditions such as: respiratory failure. History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
- •Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 6 months before enrollment/randomization
- •Concomitant severe infection
- •History of cancer (except skin cancer other than melanoma or an in situ cervical epithelioma or other solid tumour treated for curative purposes without signs of the condition and with no treatment administered in the 5 years before randomisation.)
- •Patient already included in another clinical trial with an investigational molecule
- •Prior treatment with anti-EGFr antibodies (e.g. panitumumab (Vectibix® or cetuximab / Erbitux® ) or treatment with small EGFr inhibitor molecules (e.g., erlotinib / Tarceva®)
- •Pregnant female, likely to be or currently breastfeeding, or planning to become pregnant within 6 months after the end of treatment or absence of effective contraception for males and females of childbearing age during treatment and for 6 months (male or female) after the end of treatment
- •Those deprived of their freedom or under guardianship
- •Impossibility of undergoing trial's medical follow-up for geographical, social or psychological reasons
研究组 & 干预措施
Arm A cetuximab
Experimental
cetuximab 500 mg/m2 (every 2 weeks) until progression
干预措施: Cetuximab (Drug)
Arm A cetuximab
Experimental
cetuximab 500 mg/m2 (every 2 weeks) until progression
干预措施: FOLFIRI and cetuximab (Drug)
Arm B observation
Other
observation until progression
干预措施: FOLFIRI and cetuximab (Drug)
结局指标
主要结局
Progression Free Survival at 6 months
时间窗: 6 months after start of maintenance therapy
Endpoints will include Progression assessed by CT Scan according to RECIST 1.1 criteria and Death from any cause
次要结局
未报告次要终点
研究者
研究点 (46)
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