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RECRUITING
NCT05406856
NA

PROTECT: On-line Adaptive Proton Therapy for Cervical Cancer

Sponsor: Leiden University Medical Center

View on ClinicalTrials.gov

Summary

This prospective, multicenter, nonrandomized phase-II-trial investigates in clinical practice the differences between intensity modulated proton therapy (IMPT) and standard intensity-modulated radiation therapy (IMRT) or volumetric-modulated arc therapy (VMAT) in the effects on dose-volume parameters and treatment-related morbidity for women with locally advanced cervical cancer undergoing chemoradiation.

Official title: PROTECT: On-line Adaptive Proton Therapy for Cervical Cancer to Reduce the Impact on Morbidity and the Immune System

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2022-05-02

Completion Date

2026-12-01

Last Updated

2023-10-11

Healthy Volunteers

No

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.

Locations (2)

Leiden University Medical Center

Leiden, Netherlands

Erasmus Medical Center

Rotterdam, Netherlands