Compares proton and standard radiation therapy for locally advanced cervical cancer
Tests proton radiation alongside chemotherapy in adult women with locally advanced cervical cancer.
Plain-language title generated from the registry record
Registry title: PROTECT: On-line Adaptive Proton Therapy for Cervical Cancer
Key facts
- Where
- Leiden and Rotterdam, NetherlandsSee the 2 sites
Where in Netherlands
- Leiden University Medical CenterLeiden, NetherlandsTaking people
- Erasmus Medical CenterRotterdam, NetherlandsNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Leiden University Medical Center
- Trial code
- NCT05406856
- Record updated
- 11 October 2023
- Original description
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.Read full original descriptionShow less
PROTECT: On-line Adaptive Proton Therapy for Cervical Cancer to Reduce the Impact on Morbidity and the Immune System
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.
Inclusion: 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: 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; Previous pelvic or abdominal radiotherapy; 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; Small cell cancer, melanoma and other rare histological types of the cervix; Other severe diseases such as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias; History of active primary immunodeficiency; Contraindications for weekly Cisplatin (or Carboplatin); Contraindications for the use of MRI.