JPRN-jRCTs041200113招募中1 期
Phase I study of epidermal growth factor ointment for anti-EGFR agent related skin disorders
Kiyohara Yoshio0 个研究点目标入组 34 人开始时间: 2021年3月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 34
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1)Patients with unresectable advanced or recurrent colorectal cancer histologically confirmed to be adenocarcinoma expressing RAS(KRAS / NRAS)wild type .
- •(2)Patients received anti-EGFR agent(biweekly panitumumab / cetuximab) as first or later line treatment.
- •(3)With holding of chemotherapy is needed due to Grade2 < = skin rash(other than the face), appeared in a certain area(10cm x 10cm or more).
- •*Grading of skin rash is based on modified CTCAE v5.0-JCOG specified in this study.
- •(4)ECOG performance status of 0 to 2.
- •(5)Age (at the time of informed consent): 20 years and older.
- •(6)Written informed consent was obtained after receiving a through explanation of the trial.
排除标准
- •(1)Patients received continuous high-dose corticosteroids(equivalent to prednisolone 10mg or more) within 2 months before registration (except for systemic use , e.g., for reduction of chemocerapy-related nausea )
- •(2)Women who are pregnant or breastfeeding, women who have nointention of contraception during study drug or until 6months after the final administration of the study drug, or men who desire to bear children.
- •(3)Patients hospitalized at the time of registration.
- •(4)Other patients judged by the investigator or subinvestigator to be inappropriate as a subject of this study.
研究者
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