Condition category
Cancer
Date applied
28/09/2006
Date assigned
28/09/2006
Last edited
12/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr C L Creutzberg

ORCID ID

http://orcid.org/0000-0002-7008-4321

Contact details

Leiden University Medical Center (LUMC)
Department of Clinical Oncology
PO Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 526 5120
c.l.creutzberg@lumc.nl

Additional identifiers

EudraCT number

2007-004917-33

ClinicalTrials.gov number

NCT00411138

Protocol/serial number

CKTO 2006-04; LUMC P06.031

Study information

Scientific title

Randomised phase III trial comparing concurrent chemoradiation and adjuvant chemotherapy with pelvic radiation alone in high risk and advanced stage endometrial carcinoma: PORTEC-3

Acronym

PORTEC-3

Study hypothesis

The addition of concurrent and adjuvant chemotherapy to postoperative radiation therapy will increase five year overall survival and failure-free survival of patients with high-risk and advanced stage endometrial carcinoma.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Endometrial carcinoma

Intervention

Patients are randomised (1:1) to receive external beam pelvic radiotherapy (standard arm: 48.6 Gy in 1.8 Gy fractions), or pelvic radiotherapy with concurrent chemotherapy (two cycles of cisplatin) followed by adjuvant chemotherapy (four cycles of carboplatin and paclitaxel; experimental arm).

Intervention type

Drug

Phase

Phase III

Drug names

Cisplatin, carboplatin, paclitaxel

Primary outcome measures

1. Five year actuarial overall suvival
2. Five year actuarial failure-free survival (with failure defined as relapse or death due to endometrial carcinoma or to treatment complications)

Secondary outcome measures

1. Quality of life
2. Severe treatment related morbidity
3. Five year rates of vaginal, pelvic and distant relapse

Overall trial start date

15/09/2006

Overall trial end date

01/01/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically confirmed endometrial carcinoma, with one of the following postoperative International Federation of Gynecology and Obstetrics (FIGO 1988) stages and grade:
1.1. Stage IB grade 3 with documented Lymphatic Vascular Space Invasion (LVSI)
1.2. Stage 1C grade 3
1.3. Stage II grade 3
1.4. Stage IIIA or IIIC (IIIA based on peritoneal cytology alone is only eligible if grade 3)
1.5. Stage IB or IC, stage II or stage III with serous or clear cell histology
2. World Health Organisation (WHO) performance status zero to two
3. White Blood Cells (WBC) more than or equal to 3.0 x 10^9/L
4. Platelets more than or equal to 100 x 10^9/L
5. Bilirubin less than or equal to 1.5 x Upper Normalised Limit (UNL)
6. Aspartate Aminotransferase (ASAT)/Alanine Aminotreansferase (ALAT) less than or equal to 2.5 x UNL
7. Written informed consent

As of 11/02/2011 the criteria has been updated to also include the new FIGO 2009 staging system:
Histologically confirmed endometrial carcinoma, with one of the following postoperative FIGO 2009 stages and grade:
1. Stage IA with myometrial invasion, grade 3 with documented LVSI
2. Stage IB grade 3
3. Stage II
4. Stage IIIA or IIIC; or IIIB if parametrial invasion only
5. Stage IA (with myometrial invasion), IB, II, or III with serous or clear cell histology

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

500

Participant exclusion criteria

1. Previous malignancy, except for basal cell carcinoma of the skin, less than ten years
2. Previous pelvic radiotherapy
3. Hormonal therapy or chemotherapy for this tumor
4. Macroscopic stage IIB for which Wertheim type hysterectomy
5. Prior diagnosis of Crohn's disease or ulcerative colitis
6. Residual macroscopic tumor after surgery
7. Creatinine clearance less than or equal to 60 ml/min (calculated according to Cockroft) or less than or equal to 50 ml/min (EthyleneDiamineTetraacetic Acid [EDTA] clearance, or measured creatinine clearance)
8. Impaired cardiac function, prohibiting the infusion of large amounts of fluid during cisplatin therapy
9. Peripheral Neuropathy more than or equal to grade two

Recruitment start date

15/09/2006

Recruitment end date

20/12/2013

Locations

Countries of recruitment

Australia, Canada, France, Italy, Netherlands, New Zealand, United Kingdom

Trial participating centre

Leiden University Medical Center (LUMC)
Leiden
2300 RC
Netherlands

Sponsor information

Organisation

Leiden University Medical Center (LUMC) (The Netherlands)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

KWF Kankerbestrijding

Alternative name(s)

Dutch Cancer Society

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

National Health and Medical Research Council

Alternative name(s)

NHMRC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Australia

Funder name

Cancer Australia

Alternative name(s)

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Australia

Funder name

Canadian Cancer Society Research Institute

Alternative name(s)

Société Canadienne du Cancer, CCSRI

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

Canada

Funder name

Agenzia Italiana del Farmaco, Ministero della Salute

Alternative name(s)

Italian Medicines Agency, AIFA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Italy

Results and Publications

Publication and dissemination plan

Follow-up information is needed for at least 5 years for all randomised patients, and thus follow-up, queries and completion of CRF are ongoing and the timing of final analysis of the primary endpoint of OS will not be reached before late 2017 or (most likely) in 2018. We will publish 2-year results on toxicity and quality of life in 2016.

Intention to publish date

01/01/2018

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27397040

Publication citations

Additional files

Editorial Notes

12/07/2016: Publication reference added. 03/05/2016: The overall trial end date was changed from 20/12/2013 to 01/01/2020. 17/02/2011: The overall trial end date was changed from 01/12/2011 to 01/12/2013.