JPRN-UMIN000014780已完成3 期
A randomized controlled trial of prophylactic minocycline for erlotinib-associated skin rash in non-small cell lung cancer - A randomized controlled trial of prophylactic minocycline for erlotinib-associated skin rash in non-small cell lung cancer (PEARL-Skin)
ational Hospital Organization, Thoracic Oncology Network Research Group0 个研究点目标入组 280 人开始时间: 2014年8月8日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 280
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 ot applicable(—)
- 性别
- All
入选标准
- 未提供
排除标准
- •(1) Past medical history or clinically active interstitial lung disease. (2) Concomitant skin disease or history of treatment for skin disease within 4 weeks (3) Patients with symptomatic brain metastasis (4) Uncontrolled ascites, pleural effusion or cardiac effusion. (5) Supra vena cava syndrome. (6) Patients who needs the local therapy such as operation or irradiation for symptom relief or prevention of symptomatic disease. (7) Past medical history of any malignant disease less than 5 years disease free period. (8) Receiving systemic treatment of steroid or immunosuppressant within 2 weeks prior to registration. Taking topical steroid for any skin disease. (9) No medical history of tyrosine kinase inhibitor or anti-EGFR-Abs treatment. (10) Any unresolved toxicities from prior therapy greater than NCI-CTCAE (Ver 4.03) grade 2. (11) Past medical history for hypersensitive for minocycline or erlotinib (12) Contraindication for minocycline or erlotinib. (13) Any of following gastrointestinal disorder; 1) Inability to swallow the formulated product 2) Receiving total parenteral nutrition 3) Malabsorption related past medical procedure 4) Past medical history or active inflamatory bowel disease 14) Past medical history or active severe or uncontrolled comorbidty disease. 15) Judgement by the investigator that the patient should not be participated in this trial
研究者
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