PORTEC-2: Postoperative Radiation Therapy for Endometrial Carcinoma – a multicenter randomised phase III trial comparing external beam radiation and vaginal brachytherapy.

Completed

• Conditions: Endometrial carcinoma; indication for postoperative radiation therapy.

• Registration Number: NL-OMON25442
• Lead Sponsor: eiden University Medical Center, Department of Clinical Oncology

Brief Summary

Wortman BG, Creutzberg CL, Putter H, et al: Ten-year results of the PORTEC-2 trial for high-intermediate risk endometrial carcinoma: improving patient selection for adjuvant therapy. Br J Cancer. 2018 Oct;119(9):1067-1074. doi: 10.1038/s41416-018-0310-8. Epub 2018 Oct 25. Nout RA, Putter H, Jurgenliemk-Schulz IM, et al: 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, Smit VTHB, Putter H, et al: Vaginal brachytherapy versus pelvic external beam radiotherapy for patients with endometrial carcinoma of high-intermediate risk (PORTEC-2): an open-label, non-inferiority, randomised trial. Lancet 375:816-823, 2010. Nout RA, Putter H, Jurgenliemk-Schulz IM, et al: Quality of life after pelvic radiotherapy or vaginal brachytherapy for endometrial cancer: first results of the randomized PORTEC-2 trial. J Clin Oncol 27:3547-3556, 2009.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 400

Inclusion Criteria

1. Endometrial carcinoma, with one of the following combinations of postoperative FIGO stage and age:

a. Stage 1C grade 1 or 2 and age 60 or over;

Exclusion Criteria

1. One of the following combinations of FIGO stage and age:

a. Stage 2B, 3 or 4;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
5-year actuarial vaginal relapse.

Secondary Outcome Measures

Name	Time	Method
1. 5-year overall survival and cancer-specific survival;<br /><br>2. quality of life and treatment related morbidity;<br /><br>3. 5-year rates of pelvic and distant relapse; <br /><br>4. Local control and survival after relapse.