NCT00376844

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
427

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2002

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
6.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 12, 2022

Status Verified

April 1, 2022

Enrollment Period

7 years

First QC Date

September 13, 2006

Last Update Submit

April 4, 2022

Conditions

Endometrial Cancer

Keywords

stage I endometrial carcinoma

Outcome Measures

Primary Outcomes (1)

  • Vaginal relapse

    total vaginal relapse and vaginal relapse as first failure

    5 years

Secondary Outcomes (5)

  • Rate of distant metastases

    5 years

  • Overall survival

    5 years

  • Adverse effects

    5 years

  • Health-related quality of life

    5 years

  • Pelvic relapse

    5 years

Study Arms (2)

External Beam Radiation Therapy

ACTIVE COMPARATOR

Postoperative pelvic radiotherapy

Radiation: External Beam Radiation Therapy

Vaginal Brachytherapy

EXPERIMENTAL

Postoperative vaginal brachytherapy

Radiation: Vaginal Brachytherapy

Interventions

External Beam Radiation TherapyRADIATION
Also known as: pelvic radiotherapy
External Beam Radiation Therapy
Vaginal BrachytherapyRADIATION
Also known as: internal radiation
Vaginal Brachytherapy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leiden University Medical Center

Leiden, 2300 RC, Netherlands

Location

Related Publications (7)

  • 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.

    PMID: 19944453BACKGROUND

  • 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.

    PMID: 22176868RESULT

  • 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.

    PMID: 19546404RESULT

  • 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.

    RESULT

  • 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.

    PMID: 20206777RESULT

  • 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.

    PMID: 26530748RESULT

  • 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.

    PMID: 37487144DERIVED

Related Links

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Brachytherapy

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeutics

Study Officials

  • Carien L. Creutzberg, MD, PhD

    Leiden University Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Exterbal beam radiation therapy versus vaginal brachytherapy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Radiation Oncology, Chief investigator

Study Record Dates

First Submitted

September 13, 2006

First Posted

September 15, 2006

Study Start

May 1, 2002

Primary Completion

May 1, 2009

Study Completion

April 1, 2016

Last Updated

April 12, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

After submission of a research plan and approval by the TMG data will be shared

Shared Documents
STUDY PROTOCOL, ICF, CSR

Locations

NL(1)