Induction chemotherapy followed by standard concurrent chemoradiotherapy in cervical cancer with para-aortic lymph node involvement: A phase III, multicenter, parallel-group randomized, controlled trial - ONCOCOL-01 - RC31/17-0213

Centre Hospitalier Universitaire De Toulouse0 个研究点目标入组 310 人开始时间: 2024年4月26日最近更新: 2024年8月21日

适应症

试验速览

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•Patient with cervical cancer WITH para-aortic lymph node involvement determined by either a positive 18F-FDG PET-CT (visual interpretation of metabolic activity of para-aortic lymph node, greater than the background noise), or by histological examination of para-aortic lymph nodes if negative 18F-FDG PET-CT, Signed written informed consent, Affiliated to a social security insurance or equivalent, Age =18 years, ECOG performance status of 0 to 2, FIGO stage IIIC2 or IVA WITH para-aortic lymph node involvement at the time of diagnosis, Adenocarcinoma or squamous cell carcinoma or adenosquamous carcinoma, Normal renal function (creatinine clearance =60 mL/min), Normal liver function (total bilirubin <1.5 times the upper limit of normal (ULN) and AST <3 ULN), Normal haematological assessment (platelets >100×109/L and neutrophils >1.5×109/L), Women of childbearing potential and not postmenopausal must have a negative blood serum or urine pregnancy test before starting the study treatment

•Patients who have received prior chemotherapy or radiotherapy for their cervical cancer, Pregnant or breastfeeding women, History of invasive cancer (in the last five years) other than non-melanoma skin cancer, Acute, uncontrolled cardiovascular disease, Peripheral neuropathy of CTCAE grade 3-4, Known hypersensitivity to Paclitaxel, Cisplatin or other platinum-containing compounds, Patients under legal protection

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