PROTECT: On-line Adaptive Proton Therapy for Cervical Cancer
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
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
Treatments tested in this trial
- External beam radiation therapy: IMRT/VMAT
- External beam radiation therapy: IMPT
- Cisplatin
- Brachytherapy
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Leiden University Medical Center
Lead sponsor
Erasmus Medical Center
Collaborator
HollandPTC
Collaborator
Source ClinicalTrials.gov