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PORTEC-2: Post-Operative Radiation Therapy for Endometrial Carcinoma - a multicentre randomised phase III trial comparing external beam radiation and vaginal brachytherapy
ISRCTN ISRCTN16228756
DOI 10.1186/ISRCTN16228756
ClinicalTrials.gov identifier
EudraCT number
Public title PORTEC-2: Post-Operative Radiation Therapy for Endometrial Carcinoma - a multicentre randomised phase III trial comparing external beam radiation and vaginal brachytherapy
Scientific title
Acronym PORTEC-2
Serial number at source NTR332; CKTO 2001-04; LUMC P01.146
Study hypothesis Vaginal brachytherapy, as compared to external beam pelvic radiotherapy, will provide equal 5-year vaginal control and overall survival, with less treatment related morbidity and better quality of life.
Lay summary Not provided at time of registration
Ethics approval Received from the local medical ethics committee
Study design Multicentre, randomised, active controlled, parallel group trial
Countries of recruitment Netherlands
Disease/condition/study domain Endometrial carcinoma
Participants - 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
Participants - 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
Anticipated start date 01/06/2002
Anticipated end date 01/09/2006
Status of trial Completed
Patient information material
Target number of participants 400
Interventions Patients are randomised to receive external beam pelvic radiotherapy (standard arm: 46 Gy in 2 Gy fractions in 5 weeks) or vaginal brachytherapy (study arm: HDR 21 Gy in 3 fractions of 7 Gy, each 1 week apart; or MDR 28 Gy in one session; or LDR 30 Gy in one session).
Primary outcome measure(s) 5-year actuarial vaginal relapse
Secondary outcome measure(s) 1. 5-year overall survival and cancer-specific survival
2. Quality of life and treatment related morbidity
3. 5-year rates of pelvic and distant relapse
4. Local control and survival after relapse
Sources of funding 1. The National Cancer Fund (Koningin Wilhelmina Fonds [KWF]) (Netherlands)
2. Commission for Medical Applied Research (Commissie voor Klinisch Toegepast Onderzoek [CKTO]) (Netherlands)
Trial website http://www.clinicalresearch.nl/portec2
Publications 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
Contact name Dr  C.L.  Creutzberg
  Address Leiden University Medical Centre
Department of Clinical Oncology
P.O. Box 9600
  City/town Leiden
  Zip/Postcode 2300 RC
  Country Netherlands
  Tel +31 (0)71 526 3027
  Fax +31 (0)71 526 6760
  Email c.l.creutzberg@lumc.nl
Sponsor Leiden University Medical Centre (LUMC) (Netherlands)
  Address Albinusdreef 2
P.O. Box 9600
  City/town Leiden
  Zip/Postcode 2300 RC
  Country Netherlands
  Sponsor website: http://www.lumc.nl/
Date applied 20/12/2005
Last edited 31/08/2012
Date ISRCTN assigned 20/12/2005
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