NCT05406856 PROTECT: On-line Adaptive Proton Therapy for Cervical Cancer
| NCT ID | NCT05406856 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Leiden University Medical Center |
| Condition | Uterine Cervical Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2022-05-02 |
| Primary Completion | 2025-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2022-05-02 with a primary completion date of 2025-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 * WHO 0-1 * Adequate systemic organ function: * Creatinine clearance (\> 50 cc/min) * Adequate bone marrow function : white blood cells (WBCs) ≥3.0 x 109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l * Patients must be accessible for treatment and follow-up * Written informed consent according to the local Ethics Committee requirements Exclusion Criteria: * Small cell cancer, melanoma and other rare histological types of the cervix. * History of another primary malignancy that could conceivably be active evaluated by the study physician. Examples of exception include, but are not limited to: * 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 * Previous pelvic or abdominal radiotherapy * History of active primary immunodeficiency * Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g. colitis or Crohn's disease\]) * The use of immunosuppressive drugs at baseline * Contraindications for weekly Cisplatin (or Carboplatin) * Contraindications for the use of MRI
Contact & Investigator
Stephanie M. de Boer, MD, PhD
PRINCIPAL INVESTIGATOR
Leiden University Medical Center
Frequently Asked Questions
Who can join the NCT05406856 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Uterine Cervical Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05406856 currently recruiting?
Yes, NCT05406856 is actively recruiting participants. Contact the research team at a.corbeau@lumc.nl for enrollment information.
Where is the NCT05406856 trial being conducted?
This trial is being conducted at Leiden, Netherlands, Rotterdam, Netherlands.
Who is sponsoring the NCT05406856 clinical trial?
NCT05406856 is sponsored by Leiden University Medical Center. The principal investigator is Stephanie M. de Boer, MD, PhD at Leiden University Medical Center. The trial plans to enroll 30 participants.