6/29/23, 1:41 AM PORTEC-2 Pathway Feedback Search Clinical Topics Home Studies PORTEC 2 PORTEC 2 Disease Endometrial cancer Trial question Is vaginal brachytherapy superior to pelvic radiotherapy in women with high-intermediate risk endometrial carcinoma? Study design Multi-center Open label RCT Population 427 female patients Inclusion criteria: women with high-intermediate risk endometrial cancer Key exclusion criteria: serous or clear cell carcinoma; staging lymphadenectomy; > 8 weeks interval between surgery and radiotherapy; history of previous malignancy; previous radiotherapy, hormonal or chemotherapy; Crohn's disease or ulcerative colitis Interventions N=213 vaginal brachytherapy (total dose of 21 Gy in 3 fractions of 7 Gy, with an interval of 1 week) N=214 pelvic EBRT (total dose of 46 Gy in 2 Gy daily fractions, five times per week) Primary outcome Vaginal recurrence at 10 years 3.4 % 3.4 2.5 % 2.4 1.7 % 0 8 % https://web.pathway.md/studies/reczSweXimbJYpe8i 1/2 6/29/23, 1:41 AM 0.8 % PORTEC-2 Pathway No significant difference 0.0 % Vaginal brachytherapy Pelvic external beam radiotherapy No significant difference in vaginal recurrence at 10 years (3.4% vs. 2.4%; HR 1.42, 95% CI 0.45 to 4.46) Secondary outcomes Significant increase in pelvic recurrence at 10 years (6.3% vs. 0.9%; HR 6.65, 95% CI 1.5 to 29.48) No significant difference in distant metastases at 10 years (10.4% vs. 8.9%; HR 1.25, 95% CI 0.67 to 2.33) No significant difference in overall survival at 10 years (69.5% vs. 67.6%; HR 0.94, 95% CI 0.67 to 1.32) Conclusion In women with high-intermediate risk endometrial cancer, vaginal brachytherapy was not superior to pelvic EBRT with respect to vaginal recurrence at 10 years. Reference B G Wortman, C L Creutzberg, H Putter 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. Open reference URL https://web.pathway.md/studies/reczSweXimbJYpe8i 2/2