JPRN-jRCTs031180269进行中（未招募）3 期
JCOG1412: Randomized phase III trial to confirm the superiority of pelvic and para-aortic lymphadenectomy for patients with endometrial cancer - SEPAL-P3
WATARI Hidemichi0 个研究点目标入组 590 人开始时间: 2019年3月13日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 590
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 75age old（—）
- 性别
- Female
入选标准
- •1st inclusion criteria (before surgery)
- •1. Histologically diagnosed endometrial carcinoma (endometrioid, mucinous, serous, clear cell, undifferentiated, mixed)
- •2. Preoperative IB, II, IIIA, IIIB, IIIC
- •Patients with preoperative stage IIIC must fulfill both i) diagnosed by enhanced CT or PET/CT and ii) diagnosed by enhanced CT
- •i) No para-aortic lymph node (PAN) swelling and no multiple pelvic lymph node (PLN) swelling ii) PAN swelling or multiple PLN swelling with negative PET
- •Lymph node swelling is defined as a node with 10mm or more of minor axis
- •3. No peritoneal dissemination, no distant metastasis, and no inguinal node metastasis by enhanced CT or PET/CT
- •4. No bladder invasion, no rectum invasion by enhanced MRI
- •5. 20-75 years old
- •6. ECOG performance status of 0 or 1
- •7. Body mass index<=35
- •8. No prior surgery for gastrointestinal tract (appendectomy is allowed)
- •9. No prior treatment with irradiation or chemotherapy for any malignancies
- •(exclude history of breast cancer with 5-year disease-free)
- •10. Adequate organ functions
- •i. WBC>= 3,000/mm3
- •ii. Platelet >= 100,000/mm3
- •iii. T.Bil <= 1.5 mg/dL
- •iv. AST <= 100 IU/L
- •v. ALT <= 100 IU/L
- •vi. Creatinine <= 1.5 mg/dL
- •11. Written informed consent
- •2nd inclusion criteria (during surgery)
- •1. Not suspicious for para-aortic node metastasis by inspection and palpation.
- •In case of suspicious para-aortic node metastasis, negative result by frozen section diagnosis
- •2. Not suspicious for node metastases of multiple pelvic regions by inspection and palpation.
- •In case of suspicious node metastases of multiple pelvic regions, all nodes are negative or only one region of pelvic node metastasis is allowed by frozen section diagnosis.
- •3. Not suspicious for peritoneal dissemination by inspection and palpation
- •In case of suspicious peritoneal dissemination, negative result by frozen section diagnosis
- •4. Neither suspicious for bladder invasion nor rectum invasion
排除标准
- •1. Simultaneous or metachronous (within 5 years) double cancers except carcinoma in situ or intramucosal tumor
- •2. Active systemic infections to be treated
- •3. Body temperature of 38 degrees Celsius or higher
- •4. Women during pregnancy, possible pregnancy, postpartum within 28 days or breast-feeding
- •5. Psychiatric disease
- •6. Currently treated with continuous systemic steroid, immunosuppressive agents
- •7. Uncontrolled diabetes mellitus or routine administration of insulin
- •8. Currently treated with continuous anticoagulant drug/antiplatelet agent
- •9. Uncontrolled hypertension
- •10. History of cardiac failure, unstable angina or prior myocardial infarction within 6 months
- •11. HBs antigen positive
- •12. HIV antibody positive
- •13. Interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema
- •14. Hypersensitivity to polyoxyethylated castor oil or hydrogenated castor oil
- •15. Hypersensitivity to alcohol
研究者
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