CTRI/2008/091/000016招募中3 期
Phase III Randomized Trial of Maintenance Pegylated Liposomal Doxorubicin (PLD) / Carboplatin versus without in Patients with Advanced Ovarian Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
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
入选标准
- •a.histologically proven ovarian cancer of FIGO stage III/IV
- •b.treatment with five to six cycles of Paclitaxel / Platinum regimen
- •c.attainment of a clinical defined complete response (ie, no cancer-related symptom ; normal physical examination, CT scan of the abdominal/pelvis and chest x-ray ; CA-125 level  35 U/mL)
- •d.performance status of ECOG 0, 1, 2
- •e.adequate hematopoietic function is defined as below:
- •ANC  1,500/uL
- •Platelets  100,000/uL
- •f.adequate organ function is defined as below:
- •Total bilirubin  1.5  ULN
- •ALT / AST  1.5  ULN (5.0 x ULN if hepatic metastasis)
- •Serum creatinine ≦ 1.5 × ULN
- •g.age 20-75 years old
- •h.life expectancy equal or longer than 3 months
- •i.ability to understand and willingness to sign a written informed consent document
排除标准
- •a.presence of CNS metastases (including clinical suspicion)
- •b.other malignancy with exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to entering the study
- •c.presence of other serious concomitant illness which can affect or elevate the value of CA-125, e.g.;
- •Autoimmune disease
- •Sarcoidosis
- •Chronic active hepatitis
- •Pericarditis
- •Cirrhosis of liver
- •Abdominal tuberculosis
- •Pancratitis
- •d.presence of other serious concomitant illness which might be aggravated by study medication:
- •Uncontrolled infection (active serious infections that are not controlled by antibiotics)
- •Active cardiac disease e.g. decompensate myocardial infarction within the 6-month period preceding entry into the study.
- •History of ventricular arrhythmia or congestive heart failure.
- •e.surgery within 2 weeks prior to entering the study
- •f.radiotherapy within 4 weeks prior to entering the study
- •g.concurrent chemotherapy, radiotherapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study period
- •h.mental status is not fit for clinical trial
- •i.pregnant or breast feeding women
- •j.potential child-bearing women unless using a reliable and appropriate contraceptive method.
研究者
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