6/29/23, 1:42 AM PORTEC-1 Pathway Feedback Search Clinical Topics Home Studies PORTEC 1 PORTEC 1 Disease Endometrial cancer Trial question What is the role of external beam pelvic radiotherapy in patients with endometrial carcinoma? Study design Multi-center Open label RCT Population 714 female patients Inclusion criteria: women with stage IC grade 1-2 or stage IB grade 2-3 endometrial carcinoma after surgery Key exclusion criteria: history of invasive cancer, except for basal cell carcinoma of the skin; receipt of chemotherapy; receipt of hormonal therapy; receipt of radiotherapy; interval of > 8 weeks between surgery and radiotherapy Interventions N=354 radiotherapy (external beam pelvic radiotherapy with a total dose of 46 Gy in 2 Gy daily fractions) N=360 no radiotherapy (no additional treatment after surgery) Primary outcome Locoregional recurrence at 15 years 15.5 15.5 % 11.6 % 7.8 % 5 8 https://web.pathway.md/studies/recifpQTOQacGu4Gl 1/2 6/29/23, 1:42 AM PORTEC-1 Pathway 5.8 Significant increase 3.9 % NNH = 10 0.0 % Radiotherapy No radiotherapy Significant increase in locoregional recurrence at 15 years (5.8% vs. 15.5%; HR 3.46, 95% CI 1.93 to 6.18) Secondary outcomes No significant difference in overall survival at 15 years (52% vs. 60%; ARD -8, 95% CI -18.62 to 2.62) No significant difference in failure-free survival at 15 years (50% vs. 54%; ARD -4, 95% CI -99.23 to 91.23) No significant difference in distant metastases at 15 years (9% vs. 7%; AD 2%, 95% CI -1.39 to 5.39) Safety outcomes No significant difference in second primary cancers. Conclusion In women with stage IC grade 1-2 or stage IB grade 2-3 endometrial carcinoma after surgery, radiotherapy was superior to no radiotherapy with respect to locoregional recurrence at 15 years. Reference Carien L Creutzberg, Remi A Nout, Marnix L M Lybeert et al. Fifteen-year radiotherapy outcomes of the randomized PORTEC-1 trial for endometrial carcinoma. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):e631-8. Open reference URL https://web.pathway.md/studies/recifpQTOQacGu4Gl 2/2