NCT00910676已完成2 期
Phase II Multicentric Study About Preventive Treatment of Folliculitis Induced by the EGF-R Inhibitors in Patients With Metastatic Colorectal Cancer and Treated by Cetuximab or With Non-small-cell Lung Carcinoma Treated by Erlotinib
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
- 30
- 试验地点
- 3
- 主要终点
- To reduce by 30 % the frequency of folliculitis by a local corticotherapy beginning at the same time that the treatment by EGF-R inhibitors began
研究概览
简要总结
Patients will receive local prophylactic treatment (Diprosone cream) during 8 weeks from the beginning of the EGF-R inhibitors treatment, on the areas of the body susceptible to be affected by folliculitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Indication of Cetuximab in patients with metastatic colorectal cancer in association or not with irinotecan, after failure of a chemotherapy treatment with Irinotecan OR
- •Indication of Erlotinib, in patients with metastatic Non-Small-Cell Lung Carcinoma, after failure of at least one chemotherapy treatment
- •No pre-existing cutaneous toxicity
排除标准
- •Contraindication to local corticotherapy
- •Previous history of severe hypersensibility reactions (Grade III or IV) due to Cetuximab, Irinotecan or Erlotinib
- •Betamethasone or one of excipient product allergy
研究组 & 干预措施
DIPROSONE
Experimental
干预措施: Diprosone (Drug)
结局指标
主要结局
To reduce by 30 % the frequency of folliculitis by a local corticotherapy beginning at the same time that the treatment by EGF-R inhibitors began
时间窗: 2 months of treatment by corticotherapy
次要结局
- To assess the frequency of grade I, II and III folliculitis under Cetuximab and under Erlotinib(2 months of treatment)
- To list the cutaneous side effects of the EGF-R inhibitors(2 months of treatment)
- To assess the patient quality of life with the DLQI questionnaire(2 months of treatment)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
4 期
Efficacy and Safety Study of BOTOX® Compared to Topiramate for the Prevention of Chronic Migraine in AdultsMigraine DisordersNCT02191579Allergan282
已完成
2 期
A phase II study to evaluate prophylactic treatment of dacomitinib-induced dermatologic adverse events in EGFR-mutated advanced non-small cell lung cancernon-small cell lung cancerJPRN-jRCTs071190015Takayama Koichi41
Unknown
3 期
Prophylactic Use of Milrinone After Congenital Heart Surgery in InfantsCardiac Surgical ProceduresInfantLow Cardiac Output SyndromeNCT03823781Shanghai Children's Medical Center520
已完成
1 期
A phase I clinical trial of prophylactic extended-field radiotherapy of pelvic and para-aortic lymph nodes using carbon-ion beams and concurrent cisplatin chemotherapy for locally advanced squamous cell carcinoma of the uterine cervixterine cervical cancerJPRN-UMIN000008349ational Institute of Radiological Sciences12
已完成
1 期
A phase I/II clinical trial of prophylactic extended-field radiotherapy of pelvic and para-aortic lymph nodes in locally advanced squamous cell carcinoma of the uterine cervix using carbon-ion beamsuterine cervical cancerJPRN-UMIN000016169ational Institute of Radiological Sciences20