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

NCT03469674 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 550

Last updated 2023-10-11

No results posted yet for this study

Summary

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.

Conditions

  • Endometrial Cancer Stage I
  • Endometrial Cancer Stage II

Interventions

RADIATION

Vaginal brachytherapy

Internal radiation of the vaginal vault using a vaginal cylinder, 21 Gy in 3 out-patient sessions over 2 weeks

RADIATION

External beam radiotherapy

External beam pelvic radiotherapy on a linear accelerator, 48.6 Gy in 27 out-patients sessions over 5.5 weeks

OTHER

Observation

No radiation therapy, but active follow-up and quality of life questionnaires as in the groups who have adjuvant treatment

Sponsors & Collaborators

  • Dutch Cancer Society

    collaborator OTHER

  • Comprehensive Cancer Centre The Netherlands

    collaborator OTHER

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • Carien L. Creutzberg, MD, PhD · Leiden University Medical Center, Dept of Radiation Oncology

  • Remi A. Nout, MD, PhD · ErasmusMC Dept of Radiation Oncology

  • Anne-Sophie van den Heerik, MD · Leiden University Medical Center, Dept of Radiation Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-10
Primary Completion
2024-12-31
Completion
2028-12-31

Countries

  • Austria
  • Belgium
  • Czechia
  • France
  • Germany
  • Ireland
  • Netherlands
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03469674 on ClinicalTrials.gov