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

ISRCTN	ISRCTN14387080
DOI	https://doi.org/10.1186/ISRCTN14387080
EudraCT/CTIS number	2007-004917-33
ClinicalTrials.gov number	NCT00411138
Secondary identifying numbers	CKTO 2006-04; LUMC P06.031

Submission date: 28/09/2006
Registration date: 28/09/2006
Last edited: 21/04/2022

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

http://www.cancerhelp.org.uk/trials/a-trial-looking-at-radiotherapy-and-chemotherapy-after-surgery-in-women-with-womb-cancer

Study website

Contact information

Dr C L Creutzberg
Scientific

Leiden University Medical Center (LUMC)
Department of Clinical Oncology
PO Box 9600
Leiden
2300 RC
Netherlands

ORCID ID	0000-0002-7008-4321
Phone	+31 (0)71 526 5120
Email	c.l.creutzberg@lumc.nl

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study 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(s)	Ethics approval received from the local medical ethics committee
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
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	Cisplatin, carboplatin, paclitaxel
Primary outcome measure	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 study start date	15/09/2006
Overall study end date	01/01/2020

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	500
Total final enrolment	686
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 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

Study participating centre

Leiden University Medical Center (LUMC)

Leiden
2300 RC
Netherlands

Sponsor information

Leiden University Medical Center (LUMC) (The Netherlands)
Hospital/treatment centre

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

"ROR"	https://ror.org/05xvt9f17

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

Cancer Research UK
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

National Health and Medical Research Council
Government organisation / National government

Alternative name(s): NHMRC
Location: Australia

Cancer Australia
Government organisation / National government

Location: Australia

Canadian Cancer Society Research Institute
Private sector organisation / Associations and societies (private and public)

Alternative name(s): l'Institut de recherche de la Société canadienne du cancer, CCSRI, IRSCC
Location: Canada

Agenzia Italiana del Farmaco, Ministero della Salute
Government organisation / National government

Alternative name(s): Italian Medicines Agency, Agenzia Italiana del Farmaco, Italian Medicines Agency, Ministry of Health, AIFA
Location: Italy

Results and Publications

Intention to publish date	01/01/2018
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
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.
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2016		Yes	No
Results article	results	01/02/2018		Yes	No
Results article	results	01/09/2019	30/07/2019	Yes	No
Results article	results of correlation between molecular subgroup and prognosis	10/10/2020	05/03/2021	Yes	No
Plain English results			24/03/2022	No	Yes
Results article	Radiotherapy Quality Assurance	11/12/2021	21/04/2022	Yes	No

Editorial Notes

21/04/2022: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added.
24/03/2022: Plain English results added.
05/03/2021: Publication reference added.
30/07/2019: Publication reference added.
01/12/2017: Publication reference added.
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.