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

eids Universitair Medisch Centrum0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•- 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 5, 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:
•o Creatinine clearance (> 50 cc/min)
•o 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

•- 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:
•o Malignancy treated with curative intent and with no known active disease >=5
•o 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

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