PROTECT: On-line Adaptive Proton Therapy for Cervical Cancer

Recruiting now · Not applicable

Conditions studied: Uterine Cervical Neoplasms, Locally Advanced Cervical Carcinoma

In brief

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.

Key facts

Study ID

NCT05406856

Run by

Leiden University Medical Center

People needed

30

Starts

2022-05-02

Expected to finish

2026-12-01

Last updated by the study team

2023-10-11

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Leiden University Medical Center — Leiden, Netherlands (enrolling)
• Erasmus Medical Center — Rotterdam, Netherlands

Full record on ClinicalTrials.gov

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