PORTEC-2: Post-Operative Radiation Therapy for Endometrial Carcinoma - a multicentre randomised phase III trial comparing external beam radiation and vaginal brachytherapy

eiden University Medical Centre (LUMC) (Netherlands)0 个研究点目标入组 427 人开始时间: 2005年12月20日最近更新: 2020年3月3日

适应症

试验速览

•1. Endometrial carcinoma, with one of the following combinations of postoperative FIGO stage and age:
•1.1. Stage 1C grade 1 or 2 and age 60 or over
•1.2. Stage 1B grade 3 and age 60 or over
•1.3. Stage 2A, any age, grade 1 or 2
•1.4. Stage 2A, any age, grade 3 with less than half myometrial invasion
•2. Surgery consisted of a total abdominal hysterectomy and bilateral salpingo-oophorectomy (TAH-BSO)
•3. Histologically proven adenocarcinoma; grade of differentiation determined according to the Federation of Obstetricians and Gynaecologists (FIGO)/Armed Forces Institute of Pathology (AFIP) criteria; depth of myometrial invasion documented
•4. World Health Organization (WHO) performance status 0 - 2
•5. Written informed consent

•1. One of the following combinations of FIGO stage and age:
•1.1. Stage 2B, 3 or 4
•1.2. Stage 2A and grade 3 with 50% or greater myometrial invasion
•1.3. Stage IA or IB grade 1 or 2
•1.4. Stage 1B grade 3 and age below 60
•1.5. Stage 1C grade 1 or 2 and age below 60
•1.6. Stage IC grade 3, any age
•2. Histological subtypes papillary serous carcinoma or clear cell carcinoma
•3. Routine staging lymphadenectomy
•4. Interval between the operation and start of radiotherapy exceeding 8 weeks
•5. History of any previous malignancy, except for basal cell carcinoma of the skin
•6. Previous pelvic radiotherapy
•7. Hormonal therapy or chemotherapy for this tumour
•8. Prior diagnosis of Crohn's disease or ulcerative colitis

发起方

eiden University Medical Centre (LUMC) (Netherlands)