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
This study is testing if a new type of radiation therapy called intensity modulated proton therapy can help women with advanced cervical cancer have fewer side effects and better outcomes compared to standard radiation treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Leiden University Medical Center Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 2 sites (Leiden and 1 other locations) |
| Trial ID | NCT05406856 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of intensity modulated proton therapy (IMPT) compared to standard intensity-modulated radiation therapy (IMRT) or volumetric-modulated arc therapy (VMAT) for women with locally advanced cervical cancer undergoing chemoradiation. It aims to assess the impact of these therapies on dose-volume parameters and treatment-related side effects. The study will include 30 women aged over 18 with a histological diagnosis of locally advanced cervical cancer, evaluating outcomes such as organ sparing, quality of life, and safety. The primary endpoint focuses on the dose received by pelvic bones and bowel, while secondary endpoints include various dosimetric and oncological outcomes.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with a histologically confirmed diagnosis of locally advanced cervical cancer who are eligible for chemoradiation.
Not a fit: Patients with distant metastasis or those who do not meet the inclusion criteria for treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce treatment-related toxicity and improve the quality of life for patients with locally advanced cervical cancer.
How similar studies have performed: While studies on IMPT have shown promise, this specific comparison with IMRT/VMAT in the context of locally advanced cervical cancer is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Leiden and 1 other locations
- Leiden University Medical Center — Leiden, Netherlands (Recruiting)
- Erasmus Medical Center — Rotterdam, Netherlands (Not_yet_recruiting)
Study contacts
- Principal investigator: Stephanie M. de Boer, MD, PhD — Leiden University Medical Center
- Study coordinator: Anouk Corbeau, MSc
- Email: a.corbeau@lumc.nl
- Phone: +31 71 529 7893
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.