ISRCTN52615671已完成3 期
Randomised phase III trial of paclitaxel plus carboplatin (TC) therapy versus irinotecan plus cisplatin (CPT-P) therapy as a first-line chemotherapy for clear cell carcinoma of the ovary
Greater Glasgow Health Board (North Glasgow University Hospitals Division) (UK)0 个研究点目标入组 667 人开始时间: 2010年5月12日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 667
研究概览
简要总结
2016 Results article in https://www.ncbi.nlm.nih.gov/pubmed/27400948 results
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Patients with a histological diagnosis of clear cell carcinoma of the ovary, International Federation of Gynecology and Obstetrics (FIGO) stage I to IV. All patients must have have had a appropriate surgery for ovarian carcinoma with appropriate tissue available for histological evaluation. For patients participating in the trial from the UK, Central Pathology Review will take place prior to entry to confirm patients' eligibility.
- •2. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1
- •3. Reasonable organ function: must be assessed within 14 days of registration
- •4. Patients must have signed informed consent
- •5. Patients must be enrolled within 6 weeks of comprehensive surgery
- •6. Females aged over 18 years
排除标准
- •1. Patients with a current diagnosis of epithelial ovarian cancer of low malignant potential (borderline carcinomas)
- •2. Patients with a synchronous primary endometrial cancer, or a past history of primary endometrial cancer
- •3. Prior chemotherapy or radiation to treat the current disease
- •4. Patients who received intraperitoneal chemotherapy at time of operation
- •5. Prior diagnosis of malignancy (other than non-melanoma skin cancer or other malignancies curatively treated and greater than 5 years without evidence of recurrence)
- •6. Patients with diarrhoea greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1
- •7. Patients who have received prior radiotherapy
- •8. Patients who have received prior chemotherapy
- •9. Patients with an active infection which requires antibiotics
研究者
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