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 |
| ClinicalTrials.gov (NCT) | NCT00411138 |
| Clinical Trials Information System (CTIS) | 2007-004917-33 |
| Protocol serial number | CKTO 2006-04; LUMC P06.031 |
| Sponsor | Leiden University Medical Center (LUMC) (The Netherlands) |
| Funders | KWF Kankerbestrijding, Cancer Research UK, National Health and Medical Research Council, Cancer Australia, Canadian Cancer Society Research Institute, Agenzia Italiana del Farmaco, Ministero della Salute |
- 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 of protocol
Contact information
Dr C L Creutzberg
Scientific
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 |
| c.l.creutzberg@lumc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 objectives | 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 |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Cisplatin, carboplatin, paclitaxel |
| Primary outcome measure(s) |
1. Five year actuarial overall suvival |
| Key secondary outcome measure(s) |
1. Quality of life |
| Completion date | 01/01/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 500 |
| Total final enrolment | 686 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/09/2006 |
| Date of final enrolment | 20/12/2013 |
Locations
Countries of recruitment
- United Kingdom
- Australia
- Canada
- France
- Italy
- Netherlands
- New Zealand
Study participating centre
Leiden University Medical Center (LUMC)
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 | 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 |
| Results article | Radiotherapy Quality Assurance | 11/12/2021 | 21/04/2022 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | 24/03/2022 | No | Yes | ||
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
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.
