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 | https://doi.org/10.1186/ISRCTN16228756 |
| ClinicalTrials.gov (NCT) | NCT00376844 |
| Protocol serial number | NTR332; CKTO 2001-04; LUMC P01.146 |
| Sponsor | Leiden University Medical Centre (LUMC) (Netherlands) |
| Funders | KWF Kankerbestrijding, Commission for Medical Applied Research (Commissie voor Klinisch Toegepast Onderzoek [CKTO]) (Netherlands) |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 14/02/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr C.L. Creutzberg
Scientific
Scientific
Leiden University Medical Centre
Department of Clinical Oncology
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Phone | +31 (0)71 526 3027 |
|---|---|
| c.l.creutzberg@lumc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre, randomised, active controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | PORTEC-2: Post-Operative Radiation Therapy for Endometrial Carcinoma - a multicentre randomised phase III trial comparing external beam radiation and vaginal brachytherapy |
| Study acronym | PORTEC-2 |
| Study objectives | 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. |
| Ethics approval(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Endometrial carcinoma |
| Intervention | 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). |
| Intervention type | Other |
| Primary outcome measure(s) |
5-year actuarial vaginal relapse |
| Key secondary outcome measure(s) |
1. 5-year overall survival and cancer-specific survival |
| Completion date | 01/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Female |
| Target sample size at registration | 400 |
| Total final enrolment | 427 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2002 |
| Date of final enrolment | 01/09/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Centre
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 20/07/2009 | Yes | No | |
| Results article | results | 06/03/2010 | Yes | No | |
| Results article | results | 01/07/2012 | Yes | No | |
| Results article | results | 15/11/2015 | 14/02/2020 | Yes | No |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
14/02/2020: ClinicalTrials.gov number, publication reference and total final enrolment number added.
