Condition category
Cancer
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
31/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.clinicalresearch.nl/portec2

Contact information

Type

Scientific

Primary contact

Dr C.L. Creutzberg

ORCID ID

Contact details

Leiden University Medical Centre
Department of Clinical Oncology
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 526 3027
c.l.creutzberg@lumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR332; CKTO 2001-04; LUMC P01.146

Study information

Scientific title

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

Received from the local medical ethics committee

Study design

Multicentre, randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/06/2002

Overall trial end date

01/09/2006

Reason abandoned

Eligibility

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 type

Patient

Age group

Senior

Gender

Female

Target number of participants

400

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

Trial participating centre

Leiden University Medical Centre
Leiden
2300 RC
Netherlands

Sponsor information

Organisation

Leiden University Medical Centre (LUMC) (Netherlands)

Sponsor details

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

Sponsor type

University/education

Website

http://www.lumc.nl/

Funders

Funder type

Charity

Funder name

The National Cancer Fund (Koningin Wilhelmina Fonds [KWF]) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication 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

Publication citations

  1. Results

    Nout RA, Putter H, Jürgenliemk-Schulz IM, Jobsen JJ, Lutgens LC, van der Steen-Banasik EM, Mens JW, Slot A, Stenfert Kroese MC, van Bunningen BN, Smit VT, Nijman HW, van den Tol PP, Creutzberg CL, Quality of life after pelvic radiotherapy or vaginal brachytherapy for endometrial cancer: first results of the randomized PORTEC-2 trial., J. Clin. Oncol., 2009, 27, 21, 3547-3556, doi: 10.1200/JCO.2008.20.2424.

  2. Results

    Nout RA, Smit VT, Putter H, Jürgenliemk-Schulz IM, Jobsen JJ, Lutgens LC, van der Steen-Banasik EM, Mens JW, Slot A, Kroese MC, van Bunningen BN, Ansink AC, van Putten WL, Creutzberg CL, , Vaginal brachytherapy versus pelvic external beam radiotherapy for patients with endometrial cancer of high-intermediate risk (PORTEC-2): an open-label, non-inferiority, randomised trial., Lancet, 2010, 375, 9717, 816-823, doi: 10.1016/S0140-6736(09)62163-2.

  3. Results

    Nout RA, Putter H, Jürgenliemk-Schulz IM, Jobsen JJ, Lutgens LC, van der Steen-Banasik EM, Mens JW, Slot A, Stenfert Kroese MC, Nijman HW, van de Poll-Franse LV, Creutzberg CL, Five-year quality of life of endometrial cancer patients treated in the randomised Post Operative Radiation Therapy in Endometrial Cancer (PORTEC-2) trial and comparison with norm data., Eur. J. Cancer, 2012, 48, 11, 1638-1648, doi: 10.1016/j.ejca.2011.11.014.

Additional files

Editorial Notes