EUCTR2007-004917-33-GB进行中（未招募）不适用
A Randomised Phase III Trial Comparing Concurrent Chemoradiation and Adjuvant Chemotherapy with Pelvic Radiation Alone in High Risk and Advanced Stage Endometrial Carcinoma - PORTEC-3
eiden University Medical Centre0 个研究点目标入组 670 人开始时间: 2007年12月10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
- 670
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
- •1. Histologically confirmed endometrial carcinoma, grade of differentiation determined according to the
- •FIGO/AFIP criteria, with one of the following postoperative FIGO 2009 stages45 (Appendix B); confirmed
- •at pathology review (see section 8.1):
- •a. Stage IA with myometrial invasion, grade 3 with documented lymph-vascular space invasion (LVSI)
- •b. Stage IB grade 3
- •c. Stage II
- •d. Stage IIIA or IIIC; or IIIB if parametrial invasion
- •e. Stage IA with myometrial invasion, IB, II or IIIA/C with serous or clear cell histology
- •During the initial years of the trial, FIGO 1988 staging was used (see Appendix B). Criteria using FIGO
- •1988 staging:
- •a. Stage IB grade 3 with documented lymph-vascular space invasion (LVSI)
- •b. Stage IC or IIA grade 3
- •c. Stage IIB
- •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 laparoscopic surgery, and/or lymphadenectomy
- •and/or full surgical staging, and was found after pathology diagnosis to meet the eligibility criteria,
- •inclusion in the trial is permitted.
- •3. WHO-performance status 0-2 (Appendix C)
- •4. WBC = 3.0 x 109/L.
- •5. Platelets = 100 x 109/L.
- •6. Bilirubin = 1.5 x UNL
- •7. ASAT/ALAT = 2.5 x UNL
- •8. Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 335
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 335
排除标准
- •1. Uterine sarcoma
- •2. Previous malignancy, except for basal cell carcinoma of the skin < 10 years
- •3. Previous pelvic radiotherapy
- •4. Hormonal therapy or chemotherapy for this tumor
- •5. Macroscopic stage IIB for which 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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