NCT01108107已完成2 期
Neoadjuvant Chemotherapy and Biological Treatment for Patients With Locally Advanced Colon 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
- 入组人数
- 76
- 试验地点
- 3
- 主要终点
- The frequency of patients requiring adjuvant chemotherapy based on the histological evaluation of the preparation from the operation.
研究概览
简要总结
This study will investigate
- the effect of preoperative combination chemotherapy in patients with locally advanced colon cancer with mutation in the KRAS, BRAF or PIK3CA gene
- the effect of preoperative combination chemotherapy in combination with biological treatment in patients without mutation in the KRAS, BRAF or PIK3CA gene.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 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 verified locally advanced T3 or T4 colon cancer assessed by CT scan
- •Analysis of KRAS, BRAF, PIK3CA
- •Age ≥18 år
- •Performance status ≤ 2
- •Hematology
- •ANC ≥ 1.5x10^9/l. Thrombocytes ≥ 100x10^9/l.
- •Biochemistry
- •Bilirubinaemia ≤ 3 x UNL. ALAT ≤ 5 x UNL
- •Consent to translational research
- •Fertile women must present a negative pregnancy test and use secure birth control during and 3 months after treatment.
- •Written and orally informed consent.
排除标准
- •Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment, active severe infections or other concurrent disease.
- •Peripheral neuropathy NCI grade >1
- •Other malignant disease within 5 years prior to enrollment, except basal cell squamous carcinoma of the skin and cervical carcinoma-in-situ
- •Other investigational treatment within 30 days prior to treatment start
- •History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
- •Bleeding tumors
- •Hypersensitivity to one or more of the substances
研究组 & 干预措施
Chemotherapy only
Other
Chemotherapy only, if mutations in KRAS, BRAF or PIK3CA gene
干预措施: Oxaliplatin (Drug)
Chemotherapy only
Other
Chemotherapy only, if mutations in KRAS, BRAF or PIK3CA gene
干预措施: Capecitabine (Drug)
Chemotherapy + biological treatment
Other
Addition of biological treatment, if no mutations in KRAS, BRAF, and PIK3CA genes.
干预措施: Oxaliplatin (Drug)
Chemotherapy + biological treatment
Other
Addition of biological treatment, if no mutations in KRAS, BRAF, and PIK3CA genes.
干预措施: Capecitabine (Drug)
Chemotherapy + biological treatment
Other
Addition of biological treatment, if no mutations in KRAS, BRAF, and PIK3CA genes.
干预措施: Panitumumab (Biological)
结局指标
主要结局
The frequency of patients requiring adjuvant chemotherapy based on the histological evaluation of the preparation from the operation.
时间窗: Within 1 week after surgery
次要结局
- Recurrence free survival(Up to 2 years.)
- Overall survival(Up to 2 years.)
研究者
研究点 (3)
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