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

Not Applicable

Completed

• Conditions: Endometrial carcinoma; Cancer; Malignant neoplasm of corpus uteri

• Registration Number: ISRCTN16228756
• Lead Sponsor: eiden University Medical Centre (LUMC) (Netherlands)

Brief Summary

1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19546404 2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20206777 3. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22176868 4. 2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26530748 (added 14/02/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-12-20
• Study Completion: 2006-09-01
• Last Update Posted: 3 March 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 427

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
5-year actuarial vaginal relapse

Secondary Outcome Measures

Name	Time	Method
<br> 1. 5-year overall survival and cancer-specific survival<br> 2. Quality of life and treatment related morbidity<br> 3. 5-year rates of pelvic and distant relapse<br> 4. Local control and survival after relapse<br>