KCT0005870进行中（未招募）未知
Study of Upfront surgery versus Neoadjuvant Chemotherapy Followed by Interval Debulking Surgery for Patients with Stage IIIC and IV Ovarian Cancer
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 456
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 0No Limit（—）
- 性别
- Female
入选标准
- •3.1.1 Women aged = 18 years.
- •3.1.2 Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or
- •primary peritoneal carcinoma (diagnosis by biopsy or fine needle aspiration*). Laparoscopic
- •biopsy with pictures is recommended.
- •* If fine needle aspiration (FNA) showing an adenocarcinoma, patients should satisfy the
- •following conditions: a. the patient has a pelvic mass, and b. omental cake or other metastasis
- •larger than 2 cm in the upper abdomen, or pathologic confirmed extra-abdominal metastasis,
- •and c. serum CA125/CEA ratio>25. If serum CA125/CEA ratio <25 or malignancies of other
- •origins, such as breasts and digestive tract, are suspected from symptoms, physical
- •examinations or imaging diagnosis, endoscopy or ultrasonography should be done to exclusive
- •metastasis ovarian cancer.
- •3.1.3 ECOG performance status of 0 to 2.
- •3.1.4 ASA score of 1 to 2.
- •3.1.5 Adequate bone marrow, liver and renal function to receive chemotherapy and subsequently to
- •undergo surgery:
- •? white blood cells >3,000/µL, absolute neutrophil count =1,500/µL, platelets =100,000/µL,
- •hemoglobin =9 g/dL,
- •? serum creatinine <1.25 x upper normal limit (UNL) or creatinine clearance =60 mL/min
- •according to Cockroft-Gault formula or to local lab measurement,
- •? serum bilirubin <1.25 x UNL, AST(SGOT) and ALT(SGPT) <2.5 x UNL.
- •3.1.6 Comply with the study protocol and follow-up.
- •3.1.7 Written informed consent.
排除标准
- •3.2.1 Patients with non-epithelial tumors as well as borderline tumors.
- •3.2.2 Low-grade carcinoma. (09/22/2016)
- •3.2.3 Mucinous ovarian cancer.
- •3.2.4 Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ.
- •3.2.5 Any other concurrent medical conditions contraindicating surgery or chemotherapy that could
- •compromise the adherence to the protocol.
- •3.2.6 Other conditions, such as religious, psychological and other factors, that could interfere with
- •provision of informed consent, compliance to study procedures, or follow-up.
研究者
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