30
Participants
Start Date
May 2, 2022
Primary Completion Date
July 1, 2025
Study Completion Date
December 1, 2026
External beam radiation therapy: IMRT/VMAT
EBRT is given to a total dose of 45 Gy in 25 daily fractions of 1.8 Gy in 5 weeks. Involved nodes are boosted using a simultaneous integrated boost (SIB) to reach a total EBRT plus brachytherapy dose of 60 Gy EQD2 to provide high nodal control.
External beam radiation therapy: IMPT
EBRT is given to a total dose of 45 Gy in 25 daily fractions of 1.8 Gy in 5 weeks. Involved nodes are boosted using a simultaneous integrated boost (SIB) to reach a total EBRT plus brachytherapy dose of 60 Gy EQD2 to provide high nodal control.
Cisplatin
The standard chemotherapy regimen is weekly cisplatin (40 mg/m2) for 5 weeks.
Brachytherapy
Brachytherapy is performed using a high-dose rate (HDR) after loading system to deliver a boost to any residual tumor and the cervix. Brachytherapy dose is (21-) 28 Gy in fractions of 7 Gy specified at 100% isodose around the high-risk CTV, according to the EMBRACE-II prescription protocol. The aim is to reach an equivalent dose in 2 Gy fractions including EBRT (EQD2\_D90) of the high-risk CTV between 90-95 Gy, using MRI-guided adaptive brachytherapy.
RECRUITING
Leiden University Medical Center, Leiden
NOT_YET_RECRUITING
Erasmus Medical Center, Rotterdam
Collaborators (1)
Erasmus Medical Center
OTHER
HollandPTC
INDUSTRY
Leiden University Medical Center
OTHER