- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00376844
External-Beam Radiation Therapy Compared With Vaginal Brachytherapy After Surgery for Stage I Endometrial Cancer (PORTEC-2)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Leiden, Netherlands, 2300 RC
- Leiden University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
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 |
Intervention / Treatment |
---|---|
Active Comparator: External Beam Radiation Therapy
Postoperative pelvic radiotherapy
|
Other Names:
|
Experimental: Vaginal Brachytherapy
Postoperative vaginal brachytherapy
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vaginal relapse
Time Frame: 5 years
|
total vaginal relapse and vaginal relapse as first failure
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of distant metastases
Time Frame: 5 years
|
total distant relapse and distant relapse as first failure
|
5 years
|
Overall survival
Time Frame: 5 years
|
all-cause survival (and cancer-related survival)
|
5 years
|
Adverse effects
Time Frame: 5 years
|
Types and severity graded according to EORTC-RTOG grading system
|
5 years
|
Health-related quality of life
Time Frame: 5 years
|
Cancer-specific quality of life (EORTC QLQ C-30); patient reported symptoms
|
5 years
|
Pelvic relapse
Time Frame: 5 years
|
total pelvic relapse and pelvic relapse as first failure
|
5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Carien L. Creutzberg, MD, PhD, Leiden University Medical Center
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000502033
- CKTO-2001-04 (Other Grant/Funding Number: Dutch Cancer Society)
- P01.146 (Other Identifier: LUMC Ethics Committee)
- ISRCTN16228756 (Registry Identifier: ISRCTN)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- CSR
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