RecruitingNot ApplicableNCT05406856

PROTECT: On-line Adaptive Proton Therapy for Cervical Cancer

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

Sponsor

Leiden University Medical Center

Enrollment

30 participants

Start Date

May 2, 2022

Study Type

INTERVENTIONAL

Conditions

Uterine Cervical Neoplasms Locally Advanced Cervical Carcinoma

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a more advanced form of radiation therapy — called online adaptive proton therapy — for people with cervical cancer. Proton therapy targets the tumor more precisely and may reduce side effects compared to standard radiation. **You may be eligible if...** - You have been diagnosed with cervical cancer (squamous cell, adenocarcinoma, or adenosquamous type) - Your cancer is being treated with the intent to cure, using chemoradiation (chemotherapy plus radiation) followed by brachytherapy (internal radiation) - Your treatment plan requires radiation to the pelvic and possibly abdominal lymph node regions - You do not have cancer spread beyond the para-aortic lymph nodes **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have already received radiation to the pelvis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONExternal 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.

RADIATIONExternal beam radiation therapy: IMPT

DRUGCisplatin

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

RADIATIONBrachytherapy

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.