EUCTR2007-004917-33-IT进行中（未招募）不适用
Randomized Phase III Trial Comparing Concurrent Chemoradiation and Adjuvant Chemotherapy with Pelvic Radiation Alone in High Risk and Advanced Stage Endometrial Carcinoma. - PORTEC-3
IST. DI RICERCHE FARMACOLOG. M. NEGRI0 个研究点目标入组 500 人开始时间: 2008年5月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Histologically confirmed endometrial carcinoma, grade of differentiation determined according to the FIGO/AFIP criteria, with one of the following postoperative FIGO stages (confirmed at pathology review, see section 8.1): a. Stage IB grade 3 with documented lymph-vascular space invasion (LVSI) b. Stage IC grade 3 c. Stage II (occult) grade 3 d. Stage IIIA* or IIIC *IIIA based on peritoneal cytology alone is only eligible if grade 3 e. Stage IB, IC, II or III with serous or clear cell histology 2. Recommended surgery is TAH-BSO (total abdominal hysterectomy and bilateral salpingooophorectomy). However, for a patient who has had lymphadenectomy and/or full surgical staging, and was found after PA diagnosis to meet the eligibility criteria, inclusion in the trial is permitted. 3. WHO-performance status 0-2 4. WBC ≥ 3.0 x 109/L. 5. Platelets ≥ 100 x 109/L.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Uterine sarcoma 2. History of any previous malignancy, except for basal cell carcinoma of the skin, within the last 10 years 3. Previous pelvic radiotherapy 4. Hormonal therapy or chemotherapy for this tumor 5. Macroscopic stage IIB for which radical (Wertheim type) hysterectomy has been performed 6. Prior diagnosis of Crohn s disease or ulcerative colitis 7. Residual macroscopic tumor after surgery 8. Impaired renal function: creatinine clearance ≤ 60 ml/min (calculated according to Cockroft) or ≤ 50 ml/min (EDTA clearance, or measured creatinine clearance) 9. Impaired cardiac function, prohibiting the infusion of large amounts of fluid during cisplatin therapy 10. Peripheral Neuropathy > grade 2
研究者
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