Table 3.
Ongoing trials for endometrial cancer (EC) treatment based on molecular classification.
| Trial Name | Start Date | Estimated Completion Date | Country | Phase | Trial Type | Included EC Patients | Mutation | Treatment | Primary Outcome |
|---|---|---|---|---|---|---|---|---|---|
|
PORTEC-4a
NCT03469674 |
June 2016 | Dec. 2025 | EU | III | Randomized 2:1 | HIR * | POLE CTNNB1 MMR TP53 L1CAM |
(1) Vaginal brachytherapy (2) Experimental group: observation, brachytherapy, or EBRT |
5-year vaginal recurrence |
| RAINBO | - | - | EU, USA, Canada, NZ, Australia | III | Non-randomized | POLE MMRd P53 NSMP |
(1) P53: chemoradiation + −PARPi (2) MMRd: radiation + −checkpoint inhibitor (3) NSMP: Chemoradiation vs radiation + hormonal treatment (4) POLE: no adjuvant |
5-year RFS | |
|
TAPER
NCT04705649 |
July 2020 | Dec. 2023 | Canada | II, III | Single arm | Early stage EC |
POLE NSMP |
Observation | 3-year pelvic recurrences (including vaginal) |
|
CAN-STAMP
NCT04159155 |
Nov. 2020 | Sep. 2025 | Canada | II, III | Randomized | Early & late stage | P53 serous |
Early stage: (1): Chemotherapy + chemoradiation (2) Chemotherapy Late stage: (1): Chemotherapy (2): Chemotherapy + Niraparib |
3-year RFS |
|
NRG-GY018
NCT03914612 Pembrolizumab |
July 2019 | June 2023 | Canada USA |
III | Randomized | Stage III-IV, recurrent |
MMRd | (1) Chemotherapy + placebo (2) Chemotherapy + Pembrolizumab |
5-year PFS |
|
NRG-GY020
NCT04214067 Pembrolizumab |
Feb. 2020 | Feb. 2024 | USA Puerto Rico |
III | Randomized Open label Two group |
Stage I-II, HIR ** |
MMRd | (1) Radiation + placebo (2) Radiation + Pembrolizumab |
3-year RFS |
EU European Union; HIR high-intermediate risk; CTNNB1 catenin beta 1; L1CAM L1 cell adhesion molecule; MMRd mismatch repair deficient; EBRT external beam radiation therapy; NZ New Zealand p53wt p53 wild type; NSMP no specific molecular profile; RFS recurrent free survival; PFS progression free survival; * Stage IA, grade 3; stage IB, grade ½ and age >60; stage IB grade ½ and LVSI; stage IB grade 3 without LVSI; stage II microscopic, grade 1; ** GOG criteria for HIR: age > = 70 and one risk factor; 50–69 and two risk factors; <=50 and three risk factors; risk factors: LVSI, grade 3, >50% myometrial involvement.