PROTECT: on-line adaptive proton therapy for cervical cancer to reduce the impact on morbidity and the immune system

MC0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

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•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 or the common iliac and para-aortic regions 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 (PET-CT scan)
•-Age > 18 years
•-Adequate systemic organ function:
•oCreatinine clearance (> 50 cc/min)
•oAdequate 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

•-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:
•oMalignancy treated with curative intent and with no known active disease =5 years.
•oAdequately 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

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