NL-OMON39511已完成3 期
A randomised phase III trial comparing a strategy based on molecular analysis to the empiric strategy in patients with carcinoma of an unknown primary;A la carte CUP treatment using the CancerTYPE ID test - CUP
Viecuri Medisch Centrum voor Noord-Limburg0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
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
- 18 至 99（—）
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 welldifferentiated 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.
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.
研究者
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