search
Back to results

External-Beam Radiation Therapy Compared With Vaginal Brachytherapy After Surgery for Stage I Endometrial Cancer (PORTEC-2)

Primary Purpose

Endometrial Cancer

Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
External Beam Radiation Therapy
Vaginal Brachytherapy
Sponsored by
Leiden University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Cancer focused on measuring stage I endometrial carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

INCLUSION CRITERIA:

  • 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

EXCLUSION CRITERIA:

  • 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

Sites / Locations

  • Leiden University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

External Beam Radiation Therapy

Vaginal Brachytherapy

Arm Description

Postoperative pelvic radiotherapy

Postoperative vaginal brachytherapy

Outcomes

Primary Outcome Measures

Vaginal relapse
total vaginal relapse and vaginal relapse as first failure

Secondary Outcome Measures

Rate of distant metastases
total distant relapse and distant relapse as first failure
Overall survival
all-cause survival (and cancer-related survival)
Adverse effects
Types and severity graded according to EORTC-RTOG grading system
Health-related quality of life
Cancer-specific quality of life (EORTC QLQ C-30); patient reported symptoms
Pelvic relapse
total pelvic relapse and pelvic relapse as first failure

Full Information

First Posted
September 13, 2006
Last Updated
April 4, 2022
Sponsor
Leiden University
Collaborators
Dutch Cancer Society
search

1. Study Identification

Unique Protocol Identification Number
NCT00376844
Brief Title
External-Beam Radiation Therapy Compared With Vaginal Brachytherapy After Surgery for Stage I Endometrial Cancer
Acronym
PORTEC-2
Official Title
PORTEC-2, Postoperative Radiation Therapy for Endometrial Carcinoma - A Multicenter Randomised Phase III Trial Comparing External Beam Radiation and Vaginal Brachytherapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Leiden University
Collaborators
Dutch Cancer Society

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
Keywords
stage I endometrial carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Exterbal beam radiation therapy versus vaginal brachytherapy
Masking
None (Open Label)
Allocation
Randomized
Enrollment
427 (Actual)

8. Arms, Groups, and Interventions

Arm Title
External Beam Radiation Therapy
Arm Type
Active Comparator
Arm Description
Postoperative pelvic radiotherapy
Arm Title
Vaginal Brachytherapy
Arm Type
Experimental
Arm Description
Postoperative vaginal brachytherapy
Intervention Type
Radiation
Intervention Name(s)
External Beam Radiation Therapy
Other Intervention Name(s)
pelvic radiotherapy
Intervention Type
Radiation
Intervention Name(s)
Vaginal Brachytherapy
Other Intervention Name(s)
internal radiation
Primary Outcome Measure Information:
Title
Vaginal relapse
Description
total vaginal relapse and vaginal relapse as first failure
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Rate of distant metastases
Description
total distant relapse and distant relapse as first failure
Time Frame
5 years
Title
Overall survival
Description
all-cause survival (and cancer-related survival)
Time Frame
5 years
Title
Adverse effects
Description
Types and severity graded according to EORTC-RTOG grading system
Time Frame
5 years
Title
Health-related quality of life
Description
Cancer-specific quality of life (EORTC QLQ C-30); patient reported symptoms
Time Frame
5 years
Title
Pelvic relapse
Description
total pelvic relapse and pelvic relapse as first failure
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA: 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 EXCLUSION CRITERIA: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carien L. Creutzberg, MD, PhD
Organizational Affiliation
Leiden University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2300 RC
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After submission of a research plan and approval by the TMG data will be shared
Citations:
PubMed Identifier
19944453
Citation
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.
Results Reference
background
PubMed Identifier
22176868
Citation
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.
Results Reference
result
PubMed Identifier
19546404
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
PubMed Identifier
20206777
Citation
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.
Results Reference
result
PubMed Identifier
26530748
Citation
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.
Results Reference
result
Links:
URL
https://www.clinicaltrials.gov/ct2/show/study/NCT00376844?term=portec&cond=Endometrial+Cancer&rank=1
Description
Clinical trial summary from the National Cancer Institute's PDQ® database

Learn more about this trial

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

We'll reach out to this number within 24 hrs