ACTRN12609000369224进行中（未招募）3 期
A phase III trial to establish overall survival and failure-free survival of patients with high risk and advanced stage endometrial carcinoma, treated after sugery with concurrent radiotherapy and chemotherapy, followed by adjuvant chemotherapy, in comparison with patients treated with pelvic radiation alone.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 680
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- o limit 至 o limit（—）
- 性别
- Female
入选标准
- •1. Histologically confirmed endometrial carcinoma, with one of the following postoperative International Federation of Gynecology and Obstetrics (FIGO) stages and grade:
- •a. Stage IB grade 3 with documented Lymphatic Vascular Space Invasion (LVSI)
- •b. Stage 1C grade 3
- •c. Stage II grade 3
- •d. Stage IIIA or IIIC (IIIA based on peritoneal cytology alone is only eligible if grade 3)
- •e. Stage IB or IC, stage II or stage III with serous or clear cell histology
- •2. World Health Organisation (WHO) performance status zero to two
- •3. White Blood Cells (WBC) greater than or equal to 3.0 x 10^9/L
- •4. Platelets greater than or equal to 100 x 10^9/L
- •5. Bilirubin less than or equal to 1.5 x Upper Normalised Limit (UNL)
- •6. Aspartate Aminotransferase (ASAT)/Alanine Aminotreansferase (ALAT) less than or equal to 2.5 x UNL
- •7. Written informed consent
排除标准
- •1. Previous malignancy, except for basal cell carcinoma of the skin, less than ten years
- •2. Previous pelvic radiotherapy
- •3. Hormonal therapy or chemotherapy for this tumor
- •4. Macroscopic stage IIB for which Wertheim type hysterectomy
- •5. Prior diagnosis of Crohn's disease or ulcerative colitis
- •6. Residual macroscopic tumor after surgery
- •7. Creatinine clearance less than or equal to 60 ml/min (calculated according to Cockroft) or less than or equal to 50 ml/min (EthyleneDiamineTetraacetic Acid [EDTA] clearance, or measured creatinine clearance)
- •8. Impaired cardiac function, prohibiting the infusion of large amounts of fluid during cisplatin therapy
- •9. Peripheral Neuropathy more than or equal to grade two
研究者
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