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 number	NCT00376844
Secondary identifying numbers	NTR332; CKTO 2001-04; LUMC P01.146

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

Not provided at time of registration

Study website

Contact information

Dr C.L. Creutzberg
Scientific

Leiden University Medical Centre
Department of Clinical Oncology
P.O. Box 9600
Leiden
2300 RC
Netherlands

Phone	+31 (0)71 526 3027
Email	c.l.creutzberg@lumc.nl

Study information

Study design	Multicentre, randomised, active controlled, parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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 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.
Ethics approval(s)	Received from the local medical ethics committee
Condition	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	5-year actuarial vaginal relapse
Secondary outcome measures	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
Overall study start date	01/06/2002
Overall study end date	01/09/2006

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Female
Target number of participants	400
Total final enrolment	427
Participant 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
Participant 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
Recruitment start date	01/06/2002
Recruitment end date	01/09/2006

Locations

Countries of recruitment

Netherlands

Study participating centre

Leiden University Medical Centre

Leiden
2300 RC
Netherlands

Sponsor information

Leiden University Medical Centre (LUMC) (Netherlands)
University/education

Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands

Website	http://www.lumc.nl/
"ROR"	https://ror.org/027bh9e22

Funders

Funder type

Charity

KWF Kankerbestrijding
Private sector organisation / Other non-profit organizations

Alternative name(s): The Dutch Cancer Society, Koningin Wilhelmina Fonds, DCS, KWF
Location: Netherlands

Commission for Medical Applied Research (Commissie voor Klinisch Toegepast Onderzoek [CKTO]) (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
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

Editorial Notes

14/02/2020: ClinicalTrials.gov number, publication reference and total final enrolment number added.