JPRN-UMIN000024113Enrolling By Invitation3 期
A phase III, open-label, randomized trial evaluating topical corticosteroid therapy for the facial acneiform dermatitis by EGFR Inhibitors: Stepwise rank down from potent corticosteroid.
ational Cancer Center0 个研究点目标入组 120 人开始时间: 2016年10月3日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 120
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
- 20years-old 至 80years-old（—）
- 性别
- All
入选标准
- •1) Eligible patients have following (1) or (2). (1) patient with non-small cell lung cancer with mutated EGFR, and is planned to treat with erlotinib or afatinib. (2) patient with colorectal cancer with wild type KRAS and NRAS, and is planned to treat with cetuximab or panitumumab.
- •2)Histopathologically the samples from surgery or biopsy specimen was diagnosed following (1)or (2). (1) Non-small cell lung cancer (SCC, adenocarcinoma, large cell cancer {except large cell endocrine cancer}, adenosquamous cell cancer, unclassified cancer), (2) Colorectal adenocarcinoma (including mucinous adenocarcinoma and signet ring cell carcinoma) by the 8th edition as the JSCCR guidelines for the treatment of colorectal cancer.
- •3) Unresectable or relapse after curative resection
- •4) 20 years old and more, and 79 years old and younger.
- •5) An Eastern Cooperative Oncology Group performance status of 0 or 1
- •6) No bacterial, fungal, syphilis, and viral infection of the face.
- •7) No history of EGFR inhibitor therapy (history of therapy with cytotoxic drugs is acceptable).
- •8) Absence of esophageal stenosis or obstruction
- •9) Written informed consent.
排除标准
- •1) Current topical corticosteroid therapy for facial lesion of atopic dermatitis and other skin diseases.
- •2) Presence of the metastatic skin lesions of lung or colorectal cancer.
- •3) Presence of the skin lesions including burn, frost bite, trauma or scar that influence to evaluation of the facial lesions.
- •4) Administration of following drugs: warfarin, sulphonylurea, digoxin, oral contraceptives, vitamin A analog, retinoid, steroid
- •5) History of allergy or serious side effects by minocycline hydrochloride
研究者
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