EUCTR2013-004321-83-ES进行中（未招募）不适用
A randomised phase III trial comparing a strategy based on molecular analysis to the empiric strategy in patients with carcinoma of an unknoun primary (CUP)
Institut Català d'Oncologia (ICO)0 个研究点目标入组 233 人开始时间: 2013年12月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 233
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Patients presenting with carcinoma of an unknown primary, confirmed by histo-pathological analysis (including an immunohistochemical analysis) and corresponding to one of the following histologic types: moderately or well-differentiated adenocarcinoma, poorly-differentiated adenocarcinoma, undifferentiated carcinoma, squamous-cell carcinoma.
- •2) Diagnostic work-up in keeping with Standard Options Recommandations des CAPI (Lesimple et al., 2003).
- •3) Age>18 years.
- •4) Performance status 0, 1 or 2 according to ECOG.
- •5) Good or poor prognosis CUP classified according to the GEFCAPI classification.
- •6) CUP with at least one measurable lesion.
- •7) Tumour sample available for molecular analysis.
- •8) CUP not belonging to a subgroup requiring a specific treatment.
- •9) Satisfactory haematological, renal and hepatic function.
- •10) Cardiac, respiratory and neurological function compatible with the administration of cisplatin chemotherapy.
- •11) No previous chemotherapy, for CUP.
- •12) Previous radiotherapy is acceptable, but it should be completed at least 4 weeks before the start of systemic treatment. Randomisation can be performed during this time frame.
- •13) All patients with reproductive potential must practice an effective method of birth control throughout the study. Female patients with childbearing potential must have a negative pregnancy test within 7 days before study treatment.
- •14) Information delivered to patient and informed consent form signed by the patient or legal representative.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 223
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 223
排除标准
- •1) Patients in whom the diagnosis has not been histologically confirmed (a cytological analysis alone does not permit patient entry onto the trial).
- •2) Patients with known HIV infection.
- •3) Patients with symptomatic brain metastases.
- •4) Associated disease likely to prevent the patient from receiving the treatment.
- •5) Previous history of cancer (excepted skin basocellular epithelioma or epithelioma in situ of the uterine cervix) during the 5 years before study entry.
- •6) Patients already included in another clinical trial with an experimental therapy.
- •7) Pregnant women, and women who are breastfeeding.
- •8) Compliance with trial medical follow-up impossible due to geographic, social or psychological reasons.
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