NCT03469674: PORTEC-4a

PORTEC-4a: Molecular Profile-based Versus Standard Adjuvant Radiotherapy in Endometrial Cancer

Active, enrolled Phase 3 Last updated 11 October 2023

What this trial tests

Phase 3 trial testing Vaginal brachytherapy in Endometrial Cancer Stage I in 550 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

10 June 2016

Primary endpoint
31 December 2024

31 December 2028

Quick facts

Lead sponsor	Leiden University Medical Center
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	550
Start date	10 June 2016
Primary completion	31 December 2024
Estimated completion	31 December 2028
Sites	31 locations across France, Netherlands, Belgium, Austria, Ireland, Germany, Switzerland, Czechia

Drugs / interventions tested

• Vaginal brachytherapy
• External beam radiotherapy
• Observation

Conditions studied

• Endometrial Cancer Stage I — all drugs for Endometrial Cancer Stage I →
• Endometrial Cancer Stage II — all drugs for Endometrial Cancer Stage II →

Sponsor

Leiden University Medical Center

Who can join

18 and older, female only, with Endometrial Cancer Stage I or Endometrial Cancer Stage II. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is prospective, multicenter, randomised phase III trial among women with endometrial cancer with high-intermediate risk features to investigate the role of an integrated clinicopathological and molecular risk profile to determine if participants should receive no adjuvant therapy, vaginal brachytherapy or external beam radiotherapy based on a favourable, intermediate or unfavourable profile as compared to standard adjuvant vaginal brachytherapy.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Adjuvant chemoradiotherapy versus radiotherapy alone in women with high-risk endometrial cancer (PORTEC-3): patterns of recurrence and post-hoc survival analysis of a randomised phase 3 trial.
   de Boer SM, Powell ME, Mileshkin L, Katsaros D, et al · · 2019 · cited 319× · PMID 31345626 · DOI 10.1016/s1470-2045(19)30395-x
2. Incorporation of molecular characteristics into endometrial cancer management.
   Vermij L, Smit V, Nout R, Bosse T. · · 2020 · cited 193× · PMID 31846532 · DOI 10.1111/his.14015
3. PORTEC-4a: international randomized trial of molecular profile-based adjuvant treatment for women with high-intermediate risk endometrial cancer.
   van den Heerik ASVM, Horeweg N, Nout RA, Lutgens LCHW, et al · · 2020 · cited 181× · PMID 33046573 · DOI 10.1136/ijgc-2020-001929
4. Adjuvant therapy for endometrial cancer in the era of molecular classification: radiotherapy, chemoradiation and novel targets for therapy.
   van den Heerik ASVM, Horeweg N, de Boer SM, Bosse T, et al · · 2021 · cited 140× · PMID 33082238 · DOI 10.1136/ijgc-2020-001822
5. Endometrial cancer: molecular classification and future treatments.
   Corr B, Cosgrove C, Spinosa D, Guntupalli S. · · 2022 · cited 66× · PMID 36936577 · DOI 10.1136/bmjmed-2022-000152
6. Towards Personalized Medicine: Non-Coding RNAs and Endometrial Cancer.
   Cavaliere AF, Perelli F, Zaami S, Piergentili R, et al · · 2021 · cited 57× · PMID 34442102 · DOI 10.3390/healthcare9080965
7. Molecular Classification of Endometrial Cancer and Its Impact on Therapy Selection.
   Galant N, Krawczyk P, Monist M, Obara A, et al · · 2024 · cited 46× · PMID 38892080 · DOI 10.3390/ijms25115893
8. Immune Checkpoint Inhibitors: A Promising Choice for Endometrial Cancer Patients?
   Musacchio L, Boccia SM, Caruso G, Santangelo G, et al · · 2020 · cited 43× · PMID 32503218 · DOI 10.3390/jcm9061721