PROTECT: On-line Adaptive Proton Therapy for Cervical Cancer

Prior treatment

• 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

Other illness

• 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

Other

• Contraindications for weekly Cisplatin (or Carboplatin)
• Contraindications for the use of MRI

• 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