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11 February 2012
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| [ Print-friendly version ] |
| PORTEC-2: Post-Operative Radiation Therapy for Endometrial Carcinoma - a multicentre randomised phase III trial comparing external beam radiation and vaginal brachytherapy |
| ISRCTN | ISRCTN16228756 |
| ClinicalTrials.gov identifier | |
| 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 | |
| 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 |
| 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 |
| 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 | 10/03/2010 |
| Date ISRCTN assigned | 20/12/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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