NCT02107937已完成2 期
A Randomized, Open-label, Three-arm, Multi-center Phase II Trial of Addition of DCVAC/OvCa to First Line Standard Chemotherapy in Women With Newly Diagnosed Epithelial Ovarian Carcinoma
SOTIO a.s.0 个研究点目标入组 136 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 主要终点
- Overall progression free survival (PFS)
研究概览
简要总结
The purpose of this study is to determine whether DCVAC/OvCa added to chemotherapy (carboplatin plus paclitaxel as first line chemotherapy) may result in prolongation of progression free survival (PFS).
详细描述
The purpose of this study is to determine whether DCVAC/OvCa added to Standard of Care chemotherapy (carboplatin plus paclitaxel as first line chemotherapy) may result in prolongation of progression free survival (PFS).
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Female aged ≥18 years
- •Patients with newly diagnosed, histologically confirmed, International Federation of Gynecology and Obstetrics (FIGO) stage III epithelial ovarian, primary peritoneal or fallopian tube carcinoma (serous, endometrioid or mucinous) who have undergone initial surgery up to 3 weeks before randomization and are selected to receive first line Standard of Care chemotherapy (optional prolongation to 6 weeks after surgery)
- •Optimally debulked (zero residuum) or maximal residuum <1cm
- •Eastern Cooperative Oncology Group (ECOG) Performance status 0,1,2
排除标准
- •FIGO I,II,IV epithelial ovarian cancer
- •FIGO III clear cells epithelial ovarian cancer
- •Non-epithelial ovarian cancer (OvCa), borderline tumors (tumors of low malignant potential)
- •Post-surgery residual disease with lesion(s) >1cm
- •Prior or current systemic anti-cancer therapy for ovarian cancer [for example chemotherapy, monoclonal antibody therapy (bevacizumab), tyrosine kinase inhibitor therapy, vascular endothelial growth factor (VEGF) therapy or hormonal therapy]
- •Previous or concurrent radiotherapy to the abdomen and pelvis
- •Malignancy other than epithelial ovarian cancer, except those that have been in clinical remission (CR) for a minimum of 3 years, and except carcinoma in-situ of the cervix or non-melanoma skin carcinomas
- •Patient co-morbidities:Human immunodeficiency virus (HIV) positive, human T-lymphotropic virus (HTLV) positive, Active hepatitis B (HBV), active hepatitis C (HCV), active syphilis
- •Evidence of active bacterial, viral or fungal infection requiring systemic treatment
- •Clinically significant cardiovascular disease including:
- •Symptomatic congestive heart failure Unstable angina pectoris Serious cardiac arrhythmia requiring medication Uncontrolled hypertension Myocardial infarction or ventricular arrhythmia or stroke within a 6 month period before inclusion, ejection fraction (EF) < 40 percent or serious cardiac conduction system disorders, if a pacemaker is not present
研究组 & 干预措施
DCVAC/OvCa with Standard of Care
Experimental
DCVAC/OvCa in parallel with chemotherapy (Standard of Care)
干预措施: DCVAC/OvCa with Standard of Care (Biological)
DCVAC/OvCa sequentially chemotherapy
Experimental
DCVAC/OvCa sequentially after chemotherapy
干预措施: DCVAC/OvCa sequentially chemotherapy (Biological)
Standart of Care
Active Comparator
Carboplatin and Paclitaxel is Standard of Care First Line Chemotherapy
干预措施: Standard of Care (Drug)
结局指标
主要结局
Overall progression free survival (PFS)
时间窗: 104 weeks
次要结局
- Biological progression free interval(0,10, 18, 30, 42, 54, 68, 80, 92, 104 weeks)
- Proportion of patients requiring 2nd line chemotherapy(0, 4, 6, 7, 9, 10, 12, 13, 15, 16, 18, 21, 24, 27, 30, 36, 42, 48, 54, 60, 64, 68, 74, 80, 86, 92, 98, 104 weeks)
- Frequency of Adverse Events(0, 4, 6, 7, 9, 10, 12, 13, 15, 16, 18, 21, 24, 27, 30, 36, 42, 48, 54, 60, 64, 68, 74, 80, 86, 92, 98, 104 weeks)
- Proportion of patients in remission after first line chemotherapy at 6 months(0,10, 18, 30, 42 weeks)
- Proportion of patients in remission after first line chemotherapy at 12 months(0,10, 18, 30, 42, 54, 68, 80, 92, 104 weeks)
- Immunological Response(0, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60 weeks)
- Time to 50 percent survival(0, 4, 6, 7, 9, 10, 12, 13, 15, 16, 18, 21, 24, 27, 30, 36, 42, 48, 54, 60, 64, 68, 74, 80, 86, 92, 98, 104 weeks)
研究者
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