PROTECT: On-line Adaptive Proton Therapy for Cervical Cancer

NARecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

May 2, 2022

Primary Completion Date

July 1, 2025

Study Completion Date

December 1, 2026

Conditions
Uterine Cervical NeoplasmsLocally Advanced Cervical Carcinoma
Interventions
RADIATION

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.

RADIATION

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.

DRUG

Cisplatin

The standard chemotherapy regimen is weekly cisplatin (40 mg/m2) for 5 weeks.

RADIATION

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.

Trial Locations (2)

2333 ZA

RECRUITING

Leiden University Medical Center, Leiden

3015 GD

NOT_YET_RECRUITING

Erasmus Medical Center, Rotterdam

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Erasmus Medical Center

OTHER

collaborator

HollandPTC

INDUSTRY

lead

Leiden University Medical Center

OTHER