JPRN-UMIN000016776已完成3 期
A phase III, randomized, controlled study of mFOLFOX6 + bevacizumab combination therapy versus mFOLFOX6 + panitumumab combination therapy in chemotherapy-naive patients with KRAS/NRAS wild-type, incurable/unresectable, advanced/recurrent colorectal cancer - PARADIGM study
ational Cancer Center Hospital East0 个研究点目标入组 823 人开始时间: 2015年3月23日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 823
研究概览
简要总结
For the efficacy, mFOLFOX6 + panitumumab demonstrated a statistically significant improvement in OS, the primary endpoint, as compared to mFOLFOX6 + bevacizumab in patients with RAS wild-type, left-sided metastatic colorectal cancer for both primary tumors occupying left-sided and overall.The safety profile of panitumumab was similar to what has already been reported without newly reported safety concerns.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 80years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •(1)Radiotherapy received within 4 weeks (28 days) prior to enrollment (2)Known brain metastasis or strongly suspected of brain metastasis (3)Synchronous cancers or metachronous cancers with a disease-free period of ; 5 years (excluding colorectal cancer) excluding mucosal cancers cured or be possibly cured by regional resection. (4)Body cavity fluid that requires treatment (pleural effusion, ascites, pericardial effusion, etc.) (5)Patients who do not want to use contraception to prevent pregnancy, and women who are pregnant or breast-feeding, or test positive for pregnancy (6)Nonhealing surgical wound (excluding implanted venous reservoirs) (7)Active hemorrhage requiring blood transfusion (8)Disease requiring systemic steroids for treatment (excluding topical steroids) (9)The patient who has placed colonic stent (10)Intestinal resection within 4 weeks prior to enrollment or colostomy within 2 weeks prior to enrollmentt (11)History or obvious and extensive CT findings of interstitial pulmonary disease (interstitial pneumonia, pulmonary fibrosis, etc.) (12)patients with unstable angina, myocardial infarction, cerebral hemorrhage, and have a arterial thromboembolism such as cerebral infarction, or history within 24 weeks (168 days) (except for asymptomatic lacunar infarction) (13)Serious drug hypersensitivity (14)Local or systemic active infection requiring treatment, or fever indicating infection (15)NYHA class II or higher heart failure or serious heart disease (16)Intestinal paralysis, gastrointestinal obstruction, or uncontrollable diarrhoea (incapacitating symptoms despite adequate treatment) (17)Poorly controlled hypertension (18)Poorly controlled diabetes mellitus (19)Active hepatitis B (20)Known HIV infection (21)Peripheral neuropathy of; Grade 2 by CTCAE (Japanese edition JCOG version 4.03) (22)Other patients judged by the investigator or subinvestigator to be ineligible for enrollment in the study
研究者
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