Randomized Phase III Clinical Trial of Weekly versus Tri-weekly Cisplatin Based Chemoradiation in Locally Advanced Cervical Cancer

Korea Cancer Center Hospital0 个研究点目标入组 374 人开始时间: 待定最近更新: 2021年1月28日

适应症

试验速览

暂无简介。

•3.1.1. Eligible patients will have pathologically proven primary locally advanced cervical cancer with squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma histology suitable for primary treatment with chemoradiation with curative intent
•3.1.2. FIGO stage 1B2, 2B, 3B, 4A
•3.1.3. Age 18 years or older
•3.1.4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
•3.1.5. Patients must have adequate:
•-Hematologic function: ANC = 1,500/mcl and platelets = 100,000/mcl
•-Renal function: serum creatinine = ULN or calculated creatinine clearance = 60 mL/min
•-Hepatic function: serum bilirubin = 1.5 x ULN and AST = 2.5 x ULN and ALT= 2.5 x ULN
•3.1.6. Patients must have signed an approved informed consent

•3.2.1. Patients with cervix cancer who have received any previous radiation or chemotherapy
•3.2.2. Patients assessed at presentation as requiring interstitial brachytherapy treatment
•3.2.3. FIGO stage 3A disease
•3.2.4. Para-aortic nodal involvement above the level of the common iliac nodes or L3/L4 (if biopsy proven, PET positive or > 15mm short axis diameter on CT)
•3.2.5. Patients with bilateral hydronephrosis unless at least one side has been stented and renal function fulfils the required inclusion criteria
•3.2.6. Previous chemotherapy for this tumor
•3.2.7. Evidence of distant metastases
•3.2.8. Prior diagnosis of Crohn’s disease or ulcerative colitis
•3.2.9. Patients who are pregnant or lactating
•3.2.10. History of other invasive malignancies, with the exception of non-melanoma skin cancer and in situ melanoma, who had (or have) any evidence of the other cancer present within the last 5 years
•3.2.11. Serious illness or medical condition that precludes the safe administration of the trial treatment including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

发起方

Korea Cancer Center Hospital