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van CCT (UK)

van CCT (UK)

PORTEC-4a, een onderzoek naar de waarde van een individueel moleculaire risicoprofiel om de nabehandeling na operatie voor vroeg stadium baarmoederkanker (endometriumcarcinoom) te bepalen.

- candidate number24429
- NTR NumberNTR5841
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-jun-2016
- Secondary IDsUL2011-5336, P16.054 NL56828.058.16
- Public TitlePORTEC-4a, een onderzoek naar de waarde van een individueel moleculaire risicoprofiel om de nabehandeling na operatie voor vroeg stadium baarmoederkanker (endometriumcarcinoom) te bepalen.
- Scientific TitlePORTEC-4a: Randomised Phase III Trial of molecular profile-based versus standard recommendations for adjuvant radiotherapy for women with early stage endometrial cancer
- hypothesisMolecular risk profile-based recommendations for adjuvant treatment will, in comparison to standard vaginal brachytherapy, lead to similar vaginal recurrence and recurrence-free survival in patients with high-intermediate risk endometrial carcinoma,while sparing about 50% of women postoperative vaginal brachytherapy and saving health care costs
- Healt Condition(s) or Problem(s) studiedEndometrial carcinoma
- Inclusion criteriaHistologically confirmed endometrioid type endometrial carcinoma, FIGO 2009 stage I, with one of the following combinations of stage, grade, age, and LVSI:
1. Stage IA, grade 3 (any age, with or without LVSI)
2. Stage IB, grade 1 or 2 and age >60 years
3. Stage IB, grade 1-2 with documented LVSI
4. Stage IB, grade 3 without LVSI
5. Stage II (microscopic), grade 1
WHO-performance status 0-2
Written informed consent
- Exclusion criteriaAny other stage and type of endometrial carcinoma
Histological types papillary serous carcinoma or clear cell carcinoma (at least 10% if mixed type), or undifferentiated or neuroendocrine carcinoma
Uterine sarcoma (including carcinosarcoma)
Previous malignancy (except for non-melanomatous skin cancer) < 5 yrs
Previous pelvic radiotherapy
Interval between the operation and start of radiotherapy exceeding 8 weeks
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2016
- planned closingdate1-jun-2022
- Target number of participants500
- InterventionsArm 1 (standard): vaginal brachytherapy
Arm 2 (molecular profile based recommendations for adjuvant treatment): observation, vaginal brachytherapy or external beam radiotherapy
- Primary outcomevaginal recurrence
- Secondary outcomerecurrence-free survival
pelvic and distant recurrence
patient-reported quality of life
adverse events
health care costs
- Timepoints5-year rates of vaginal control, survival, adverse events, quality of life, health care costs
Evaluation at 6 month intervals
- Trial web
- statusopen: patient inclusion
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Dutch Cancer Society
- PublicationsMolecular profile data based on combined PORTEC-1 and PORTEC-2 trial cohort:
Stelloo et al, Clinical Cancer Research 2016 PORTEC-2 trial results: Nout et al, Lancet 2010.
- Brief summaryCurrent standard postoperative treatment for women with early stage, high-intermediat risk endometrial cancer is vaginal brachytherapy, which provides excellent local control with minimal side effects. However, as there is no difference in survival, as 7-8 women have to be treated to prevent 1 vaginal recurrence, and as patients with local recurrence can be effectively salvaged, the question is if this is overtreatment and more effective prediction of the risk of relapse can save many women vaginal brachytherapy and reduce health care costs.
In recent years, the genomic characterisation of endometrial cancer as published by The Cancer Genome Atlas and subsequent independent studies of molecular risk factors such as POLE, L1CAM, MSI, p53 have provided insight into the mutations underlying endometrial cancer development and progression, and have shown strong prognostic impact. In the translational research of PORTEC1- and 2 trials (900 pts) an integrated molecular risk profile has been determined which subclassifies patients with early stage, high-intermiadate risk endometrial cancer as favorable, intermediate or unfavorable, with significantly better prognostic power than the clinicopathologic risk assessment. In the PORTEC-4a trial, this integrated molecular risk profile will be used to evaluate the patient's individual risk and determine adjuvant treatment (favorable: observation; intermediate: vaginal brachytherapy; unfavorable: extermal beam radiotherapy) and compared to standard indication for vagial brachytherapy for all patiente with early stage, high-intermediate risk features.
Objectives and design:
Patient with early stage, high-intermediate risk endometrial carcinoma will be randomly assigned (1:2) to vaginal brachytherapy (standard arm) or molecular profile-based recommendations for either observation, vaginal brachytherapy or external beam radiotherapy (investigational arm).
The first cohort of 50 patients shall be included in a pilot phase of the study, which will test the acceptability and logistics of this multicentre study. If results are positive, the trial will continue to include 500 evaluable patients, with international participating groups.
- Main changes (audit trail)
- RECORD1-jun-2016 - 28-jun-2016

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