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PROTECT: On-line Adaptive Proton Therapy for Cervical Cancer

ConditionsUterine Cervical NeoplasmsLocally Advanced Cervical Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorLeiden University Medical Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed diagnosis of cervical cancer (squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma, HPV positive or negative) with an indication for curative treatment with primary chemoradiation with concurrent cisplatin followed by 3D image-guided adaptive brachytherapy.

Indication to include the common iliac region (minimum 5, maximum 8) or the common iliac and para-aortic regions (minimum 7, maximum 10) into the elective clinical target volume of the external beam radiotherapy.

No distant metastasis beyond the para-aortic lymph node chain as determined by diagnostic imaging (CT or PET-CT scan)

Age ≥ 18 years

Disqualifiers

Small cell cancer, melanoma and other rare histological types of the cervix.

Malignancy treated with curative intent and with no known active disease ≥5 years.

Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.

Other severe diseases such as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias

Trial design

Design model

Sequential

Treatments tested in this trial

  • External beam radiation therapy: IMRT/VMAT

    Radiation

    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

    Radiation

    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

    Drug

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

  • Brachytherapy

    Radiation

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: IMRT/VMAT groupActive comparator 3 interventions
Group B: IMPT groupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Dmean to the pelvic bones

Mean dose to the pelvic bones (Gy).

Time frame
During treatment
2

Mean V15Gy to the bowel

Mean volume of the bowel (cc) receiving 15Gy.

Time frame
During treatment

Secondary outcomes

1

Key dosimetric parameters of the bladder

Mean volume of the bladder (%) receiving greater than or equal to 15, 30, and 40Gy.

Time frame
During treatment
2

Key dosimetric parameters of the rectum

Mean volume of the rectum (%) receiving greater than or equal to 15, 30, and 40Gy.

Time frame
During treatment
3

Key dosimetric parameters of the sigmoid

Mean volume of the sigmoid (%) receiving greater than or equal to 15, 30, and 40Gy.

Time frame
During treatment
4

Key dosimetric parameters of the bowel

Mean volume of the bowel (cc) receiving greater than or equal to 30 and 40Gy.

Time frame
During treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Leiden University Medical Center

Lead sponsor

Erasmus Medical Center

Collaborator

HollandPTC

Collaborator

Source ClinicalTrials.gov
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