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

October 10, 2023 updated by: Carien Creutzberg, Leiden University Medical Center

Randomised Phase III Trial of Molecular Profile-based Versus Standard Recommendations for Adjuvant Radiotherapy for Women With Early Stage Endometrial Cancer: PORTEC-4a Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Adjuvant therapy for women with endometrial cancer has increasingly been tailored to prognostic factors to prevent overtreatment and select those women for adjuvant treatment who will have a clinically relevant reduction of the risk of relapse by the adjuvant treatment. Risk profiles have traditionally been based on clinicopathological factors such as age, stage, grade, LVSI and depth of invasion. Newer, both molecular-genetic (the cancer genome atlas subgroups) or immunohistochemistry-based (L1-CAM) risk factors have become available which are strongly related to outcomes and risk of cancer spread. In a comprehensive analysis of the PORTEC-1 and-2 biobank an integrated clinicopathological and molecular risk profile was determined which separated the current high-intermediate risk group of endometrial cancer in 3 separate groups (favourable, intermediate or unfavourable) with clearly separated outcomes, which is now prospectively tested in the clinic to determine adjuvant treatment. This is the first randomised trial using the molecular risk factors to assign adjuvant treatment for women with stage I-II high-intermediate risk endometrial cancer.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
550

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Karen Verhoeven-Adema, PhD
  • Phone Number: +3188 234 6125
  • Email: portec@iknl.nl

Study Locations

  • Austria
      • Vienna, Austria
        • Medical University, Vienna
  • Belgium
      • Gent, Belgium
        • University Hospital Gent
  • Czechia
      • Praha, Czechia
        • CEEGOG, General Faculty Hospital and First Faculty of Medicine, Charles University, Prague
  • France
      • Paris, France
        • Hôpital Européen Georges-Pompidou
      • Paris, France
        • Hôpital Tenon
      • Paris, France
        • GINECO group - Institut Goustave Roussy
  • Germany
      • Berlin, Germany
        • Sankt Gertrauden Krankenhaus
      • Düsseldorf, Germany
        • Kaiserswerther Diakonie
      • Essen, Germany
        • Evang. Kliniken Essen-Mitte
      • Heidelberg, Germany
        • Universitätsklinikum Heidelberg
      • Lübeck, Germany
        • Universitätsklinikum Schleswig-Holstein, Campus Lübeck
      • Münich, Germany
        • Rotkreuzklinikum München
      • Tübingen, Germany
        • University Hospital
  • Ireland
      • Dublin, Ireland
        • CancerTrials Ireland - St James Hospital (SLRON SJH)
      • Dublin, Ireland
        • CancerTrials Ireland - St Luke's Hospital (SLRON SLH)
  • Netherlands
      • Amsterdam, Netherlands
        • Academic Medical Center
      • Amsterdam, Netherlands
        • NKI / Antoni van Leeuwenhoekhuis
      • Arnhem, Netherlands
        • Radiation Therapy Group
      • Den Haag, Netherlands
        • Haaglanden Medical Center
      • Eindhoven, Netherlands
        • Catharina Hospital
      • Groningen, Netherlands
        • University Medical Center Groningen
      • Leeuwarden, Netherlands
        • Radiotherapy Institute Friesland
      • Leiden, Netherlands
        • Leiden University Medical Center
      • Maastricht, Netherlands
        • MAASTRO radiation oncology clinic
      • Nijmegen, Netherlands
        • Radboud University Medical Center
      • Rotterdam, Netherlands
        • ErasmusMC Cancer Center
      • Tilburg, Netherlands
        • Verbeeten Institute
      • Utrecht, Netherlands
        • University Medical Center Utrecht
      • Vlissingen, Netherlands
        • Zuidwest Radiotherapy Institute
      • Zwolle, Netherlands
        • Isala Clinics
  • Switzerland
      • Lucerne, Switzerland
        • Kantonsspital Frauenklinik Lucerne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically confirmed endometrioid type endometrial carcinoma, International Federation of Gynecology and Obstetrics (FIGO) 2009 stage I, with one of the following combinations of stage, grade, age, and lymph-vascular space invasion (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
  • World Health Organization (WHO)-performance status 0-2
  • Written informed consent

Exclusion Criteria:

  • Any other stage and type of endometrial carcinoma
  • Histological types 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
  • Expected interval between the operation and start of radiotherapy exceeding 8 weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Molecular profile based treatment
Determination of the integrated clinicopathological and molecular profile to determine adjuvant treatment: observation for favourable profile; vaginal brachytherapy for intermediate profile; external beam radiotherapy for unfavourable profile
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
Active Comparator: Vaginal brachytherapy
Adjuvant vaginal brachytherapy (standard treatment)
Radiation: Vaginal brachytherapy
Internal radiation of the vaginal vault using a vaginal cylinder, 21 Gy in 3 out-patient sessions over 2 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Vaginal recurrence
Time Frame: 5 years
Total vaginal recurrence and vaginal recurrence as first failure
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 5 years
Treatment-related symptoms according to CTCAE v 4.0
5 years
Health-related cancer-specific quality of life
Time Frame: 5 years
Cancer-specific quality of life (European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQC-30) - clinically relevant changes on QLQC30 functioning scales, general quality of life and general cancer symptoms
5 years
Endometrial cancer-related symptoms and quality of life
Time Frame: 5 years
Endometrial cancer-related specific symptoms (EORTC EN24 module)- clinically relevant changes on these scales (quite a bit/very much vs no or mild symptoms)
5 years
Relapse-free survival
Time Frame: 5 years
Relapse-free survival (survival without relapse)
5 years
Survival
Time Frame: 5 years
Overall survival (all-cause death)
5 years
5-year vaginal control including treatment for relapse
Time Frame: 5 years
Long-term local control including salvage treatment for local relapse
5 years
Pelvic recurrence (total)
Time Frame: 5 years
Total pelvic recurrences
5 years
Pelvic recurrence as first failure
Time Frame: 5 years
Pelvic recurrence as first failure
5 years
Distant recurrence (total)
Time Frame: 5 years
Total distant recurrences
5 years
Distant recurrence as first failure
Time Frame: 5 years
Distant recurrence as first failure
5 years
Endometrial cancer related health care costs
Time Frame: 5 years
All hospital based health care costs used with primary treatment or during followup for treatment of adverse events and/or treatment for relapse
5 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Recurrence (vaginal and total) per risk profile
Time Frame: 5 years
Vaginal, pelvic and distant relapse split by risk profile and compared between the 2 arms
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Leiden University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Comprehensive Cancer Centre The Netherlands
Dutch Cancer Society

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Carien L. Creutzberg, MD, PhD, Leiden University Medical Center, Dept of Radiation Oncology
  • Principal Investigator: Remi A. Nout, MD, PhD, ErasmusMC Dept of Radiation Oncology
  • Principal Investigator: Anne-Sophie van den Heerik, MD, Leiden University Medical Center, Dept of Radiation Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 10, 2016

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P16.054
  • UL2011-5336 (Other Grant/Funding Number: Dutch Cancer Society)
  • ISRCTN11659025 (Registry Identifier: ISRCTN Registry)
  • NTR5841 (Registry Identifier: Netherlands Trials Registry)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Specifics will be decided and made public on website at a later stage, most probably from 5 years after final publication onwards

IPD Sharing Time Frame

From 5 years after final publication onwards

IPD Sharing Access Criteria

Upon written application with a clear decription of aim, methods and analysis plan, publication plan, after approval from the study team

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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