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AzTrials

Endometrial CancerPhase 3PORTEC-2NCT00376844

External-Beam Radiation Therapy Compared With Vaginal Brachytherapy After Surgery for Stage I Endometrial Cancer

A Phase 3 study testing External Beam Radiation Therapy and Vaginal Brachytherapy in people with Endometrial Cancer, run by Leiden University at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: External-beam radiation therapy uses high-energy x-rays to kill tumor cells. Implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
External Beam Radiation Therapy and Vaginal Brachytherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
427 participants
Where
1 siteNetherlands
Study dates
May 2002to Apr 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of FIGO 1988 stage I-IIA endometrial cancer, meeting 1 of the following criteria:
  • Age ≥60, stage IC grade 1 or 2 with deep (≥ 50%) myometrial invasion
  • Age ≥60, stage IB grade 2 or 3 (with < 50% myometrial invasion)
  • Stage IIA, any age
  • No grade 3 endometrial carcinoma with deep myometrial invasion
  • Total abdominal hysterectomy and bilateral salpingo-oophorectomy required prior to randomisation
  • WHO performance status 0-2

Who cannot join

  • Serous or clear cell histology or uterine sarcoma
  • staging lymphadenectomy
  • interval between surgery and radiotherapy > 8 weeks
  • history of previous malignant disease (except basal cell carcinoma of skin)
  • previous radiotherapy, hormonal therapy or chemotherapy
  • diagnosis of Chrohn's disease or ulcerative colitis

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Leiden University Medical Center

    Leiden, 2300 RC

Other trials in Netherlands

About this study

Official title: PORTEC-2, Postoperative Radiation Therapy for Endometrial Carcinoma - A Multicenter Randomised Phase III Trial Comparing External Beam Radiation and Vaginal Brachytherapy

RATIONALE: External-beam radiation therapy uses high-energy x-rays to kill tumor cells. Implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving external-beam radiation therapy or implant radiation therapy after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether radiation therapy is more effective than observation when given after surgery in treating stage I endometrial cancer.

PURPOSE: This randomized phase III trial is studying external-beam radiation therapy or implant radiation therapy to see how well they work compared with observation in treating patients who have undergone surgery for stage I endometrial cancer.

Read the detailed description

OBJECTIVES:

  • Compare the rate of 5-year locoregional relapse in patients undergoing external-beam radiotherapy or vaginal brachytherapy vs observation only after surgery for stage I endometrial cancer.
  • Compare 5-year rate of distant metastases in these patients.
  • Determine overall survival rate in these patients.
  • Determine prognostic factors for relapse and morbidity.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo either vaginal brachytherapy or external-beam radiotherapy.
  • Arm II: Patients are observed and undergo no further treatment. After completion of study treatment, patients are followed for approximately 83 days.

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

Being tested
External Beam Radiation Therapy, Vaginal Brachytherapy
Keywords
stage I endometrial carcinoma
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • External Beam Radiation TherapyRadiation

    Also called pelvic radiotherapy

  • Vaginal BrachytherapyRadiation

    Also called internal radiation

Study groups in NCT00376844
Study groupRoleWhat they receive
External Beam Radiation TherapyActive comparatorPostoperative pelvic radiotherapy
Receives: Radiation: External Beam Radiation Therapy
Vaginal BrachytherapyExperimentalPostoperative vaginal brachytherapy
Receives: Radiation: Vaginal Brachytherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vaginal relapse

    total vaginal relapse and vaginal relapse as first failure

    Measured: 5 years

Secondary outcomes (5)

  1. Rate of distant metastases

    total distant relapse and distant relapse as first failure

    Measured: 5 years

  2. Overall survival

    all-cause survival (and cancer-related survival)

    Measured: 5 years

  3. Adverse effects

    Types and severity graded according to EORTC-RTOG grading system

    Measured: 5 years

  4. Health-related quality of life

    Cancer-specific quality of life (EORTC QLQ C-30); patient reported symptoms

    Measured: 5 years

  5. Pelvic relapse

    total pelvic relapse and pelvic relapse as first failure

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2006 (estimated)
  2. Study startMay 2002
  3. Primary completionMay 2009
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Exterbal beam radiation therapy versus vaginal brachytherapy
Masking
None (open label)
Enrolment
427 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00376844
Sponsor's protocol ID
CDR0000502033
Other IDs
CKTO-2001-04, P01.146, ISRCTN16228756
Acronym
PORTEC-2
Status last verified
Apr 2022
First submitted
13 Sep 2006
Last updated
12 Apr 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: After submission of a research plan and approval by the TMG data will be shared

Publications

  • McCloskey SA, Tchabo NE, Malhotra HK, Odunsi K, Rodabaugh K, Singhal P, Lele S, Jaggernauth W. Adjuvant vaginal brachytherapy alone for high risk localized endometrial cancer as defined by the three major randomized trials of adjuvant pelvic radiation. Gynecol Oncol. 2010 Mar;116(3):404-7. doi: 10.1016/j.ygyno.2009.06.027. Epub 2009 Nov 27.

    PubMed 19944453

  • Nout RA, Putter H, Jurgenliemk-Schulz IM, Jobsen JJ, Lutgens LC, van der Steen-Banasik EM, Mens JW, Slot A, Stenfert Kroese MC, Nijman HW, van de Poll-Franse LV, Creutzberg CL. Five-year quality of life of endometrial cancer patients treated in the randomised Post Operative Radiation Therapy in Endometrial Cancer (PORTEC-2) trial and comparison with norm data. Eur J Cancer. 2012 Jul;48(11):1638-48. doi: 10.1016/j.ejca.2011.11.014. Epub 2011 Dec 14.

    PubMed 22176868

  • Nout RA, Putter H, Jurgenliemk-Schulz IM, Jobsen JJ, Lutgens LC, van der Steen-Banasik EM, Mens JW, Slot A, Stenfert Kroese MC, van Bunningen BN, Smit VT, Nijman HW, van den Tol PP, Creutzberg CL. Quality of life after pelvic radiotherapy or vaginal brachytherapy for endometrial cancer: first results of the randomized PORTEC-2 trial. J Clin Oncol. 2009 Jul 20;27(21):3547-56. doi: 10.1200/JCO.2008.20.2424. Epub 2009 Jun 22.

    PubMed 19546404

  • Nout RA, Putter H, Jürgenliemk-Schulz IM, et al.: Vaginal brachytherapy versus external beam pelvic radiotherapy for high-intermediate risk endometrial cancer: Results of the randomized PORTEC-2 trial. [Abstract] J Clin Oncol 26 (Suppl 15): A-LBA5503, 2008.

  • Nout RA, Smit VT, Putter H, Jurgenliemk-Schulz IM, Jobsen JJ, Lutgens LC, van der Steen-Banasik EM, Mens JW, Slot A, Kroese MC, van Bunningen BN, Ansink AC, van Putten WL, Creutzberg CL; PORTEC Study Group. Vaginal brachytherapy versus pelvic external beam radiotherapy for patients with endometrial cancer of high-intermediate risk (PORTEC-2): an open-label, non-inferiority, randomised trial. Lancet. 2010 Mar 6;375(9717):816-23. doi: 10.1016/S0140-6736(09)62163-2.

    PubMed 20206777

  • de Boer SM, Nout RA, Jurgenliemk-Schulz IM, Jobsen JJ, Lutgens LC, van der Steen-Banasik EM, Mens JW, Slot A, Stenfert Kroese MC, Oerlemans S, Putter H, Verhoeven-Adema KW, Nijman HW, Creutzberg CL. Long-Term Impact of Endometrial Cancer Diagnosis and Treatment on Health-Related Quality of Life and Cancer Survivorship: Results From the Randomized PORTEC-2 Trial. Int J Radiat Oncol Biol Phys. 2015 Nov 15;93(4):797-809. doi: 10.1016/j.ijrobp.2015.08.023. Epub 2015 Aug 18.

    PubMed 26530748

  • Horeweg N, Nout RA, Jurgenliemk-Schulz IM, Lutgens LCHW, Jobsen JJ, Haverkort MAD, Mens JWM, Slot A, Wortman BG, de Boer SM, Stelloo E, Verhoeven-Adema KW, Putter H, Smit VTHBM, Bosse T, Creutzberg CL; PORTEC Study Group. Molecular Classification Predicts Response to Radiotherapy in the Randomized PORTEC-1 and PORTEC-2 Trials for Early-Stage Endometrioid Endometrial Cancer. J Clin Oncol. 2023 Sep 20;41(27):4369-4380. doi: 10.1200/JCO.23.00062. Epub 2023 Jul 24.

    PubMed 37487144

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing External Beam Radiation Therapy and Vaginal Brachytherapy in people with Endometrial Cancer, run by Leiden University at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vaginal relapse (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00376844, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.

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