Adaptive Proton Therapy for Cervical Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Immunotherapy Plus Carbon Ion Radiotherapy for Locally Advanced Cervical Cancer

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  Recruiting Zhejiang Cancer Hospital · Hangzhou, Zhejiang · NCT07702838

• Dual PD1/CTLA4 immunotherapy with chemotherapy before surgery for locally advanced cervical cancer

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• Cadonilimab with chemotherapy followed by concurrent chemoradiotherapy for locally advanced cervical cancer

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  Recruiting Phase 3 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07400536

• Radiomic MRI model to predict response to chemoradiotherapy in locally advanced cervical cancer

  This project tests whether MRI-based radiomic features can predict how women with locally advanced cervical cancer will respond to combined chemotherapy and radiation.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.