CTRI/2008/091/000016未知3 期
Phase III Randomized Trial of Maintenance Pegylated Liposomal Doxorubicin (PLD) / Carboplatin versus without in Patients with Advanced Ovarian Cancer
适应症
试验速览
- 阶段
- 3 期
- 试验地点
- 1
- 主要终点
- To determine progression free survival of Pegylated Liposomal Doxorubicin (PLD) / Carboplatin or without in patients with advanced ovarian cancer
研究概览
简要总结
This is a randomized openlabel parallel group clinical trial. This will be done in Taiwan, HongKong and India. It is targeting to recruit 290 evaluable subjects from all the couuntries. For India there will be one centre and the target recruitment will be 10 subjects.Patients with advanced ovarian cancer who have been treated with surgery and 6 cycles of Paclitaxel/Carboplatin chemotherapy will be selected. Randomization will be to either continued chemo therapy with Lipodox/Carboplatin or no chemotherapy. the patients will be followed up for 3 years for recurrence of illness and to study the progression free survival with the maintainence chemotherapy.
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
入选标准
- •a.histologically proven ovarian cancer of FIGO stage III/IVb.treatment with five to six cycles of Paclitaxel / Platinum regimenc.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/uLf.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 × ULNg.age 20-75 years oldh.life expectancy equal or longer than 3 monthsi.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 studyc.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Pancratitisd.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 studyf.radiotherapy within 4 weeks prior to entering the studyg.concurrent chemotherapy, radiotherapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study periodh.mental status is not fit for clinical triali.pregnant or breast feeding womenj.potential child-bearing women unless using a reliable and appropriate contraceptive method.
结局指标
主要结局
To determine progression free survival of Pegylated Liposomal Doxorubicin (PLD) / Carboplatin or without in patients with advanced ovarian cancer
时间窗: 48 months since randomisation
次要结局
- To assess and compare Quality-of-Life in each armTo determine the overall survival (OS) in each armTo assess the safety profiles(48 Months since randomisation)
研究者
研究点 (1)
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