NCT00126269Unknown3 期
A Randomized Phase III Trial Comparing Cisplatin With or Without Gemcitabine in Patients With Carcinoma of Unknown Primary and a Predicted Favorable Prognosis
适应症
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 192
- 试验地点
- 2
- 主要终点
- Overall survival
研究概览
简要总结
This is a randomized phase III trial comparing cisplatin with or without gemcitabine in patients with carcinoma of unknown primary and a predicted favorable prognosis.
The purpose of this trial is to compare the overall survival rates of patients with carcinoma of unknown primary (CUP) and a predicted favorable prognosis according to the French classification treated with cisplatin with or without gemcitabine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Patients older than 18 years
- •Evidence of CUP based on histologic examination
- •Negative search for the primary tumor site using recommended guidelines
- •Disease classified as good prognosis according to the French classification criteria: *performance status >2 and *normal serum LDH
- •No prior chemotherapy
- •No previous carcinoma, except basal-cell carcinoma of the skin
- •Adequate renal function: measured or calculated creatinine clearance > 60 ml/min
- •Absolute granulocyte count ≥ 1,500/mm3; platelets ≥ 100,000 mm3; bilirubin ≤ 1.5 fold the upper normal value
- •Signed informed consent
排除标准
- •Patients infected by the Human Immunodeficiency Virus (HIV)
- •CUP belonging to one of the following subgroups: 1) Axillary lymph node of an adenocarcinoma in a woman; 2) Serous adenocarcinoma of the peritoneum in a woman; 3) Undifferentiated carcinoma of the middle line in a young man; 4)Squamous-cell carcinoma; 5) Neuroendocrine carcinoma; 6) Bone metastases with elevated serum prostate specific antigen (PSA) in a man
- •Patients who do not fit inclusion criteria.
结局指标
主要结局
Overall survival
次要结局
- Toxicity
- Progression-free survival
- Quality of life
- Response rate
研究者
研究点 (2)
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