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PROTECT: On-line Adaptive Proton Therapy for Cervical Cancer

NCT05406856 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-10-11

No results posted yet for this study

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.

Conditions

  • Uterine Cervical Neoplasms
  • Locally 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.

Sponsors & Collaborators

  • Erasmus Medical Center

    collaborator OTHER

  • HollandPTC

    collaborator INDUSTRY

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • Stephanie M. de Boer, MD, PhD · Leiden University Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-02
Primary Completion
2025-07-01
Completion
2026-12-01

Countries

  • Netherlands

Study Locations

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Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05406856 on ClinicalTrials.gov