JPRN-jRCTs031180178进行中（未招募）3 期
JCOG1203: A non-randomized confirmatory study to expand the indication of fertility-sparing surgery for patients with epithelial ovarian cancer - FSS for EOC
SATOH Toyomi0 个研究点目标入组 600 人开始时间: 2019年3月5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
- 600
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
- >= 16age old 至 <= 42age old（—）
- 性别
- Female
入选标准
- •(1) To fulfill I or II
- •I. When tumor is detected in pelvic enhanced MRI and CT within 12 weeks (84 days) before registration and it is presumed ovarian cancer (neither surgery nor biopsy for ovarian tumor before registration), both of the followings are fulfilled:
- •1) Existence of ovarian tumor with solid part which is suspected as epithelial ovarian cancer
- •2) No Lymph node or distant metastasis by imaging examination
- •II. When incomplete staging surgery is performed on a patient with ovarian tumor by laparotomy or laparoscopic surgery within 84 days before registration and the tumor is diagnosed as epithelial ovarian cancer histologically by some specimens of resected ovarian tumor or biopsy at surgery within 84 days before registration, the following (1) to (4) are fulfilled:
- •1) Diagnosed as either i), ii) or iii)
- •i) Clear cell histology (CCH)
- •ii) Non-clear cell histology epithelial cancer [serous, mucinous, endometrioid] (non-CCH) Grade 1
- •iii) Non-clear cell histology epithelial cancer [serous, endometrioid] (non-CCH) Grade 2
- •2) Possibility of one of the following stages (FIGO 2014)
- •i) Clear cell histology: stage IA
- •ii) Non-clear cell histology: stage IC (unilateral)
- •3) Needing to receive re-staging laparotomy
- •4) The uterus and the other ovary being left
- •(2) The patient wishes to receive FSS by informed consent.
- •(3) Keeping an ability of childbirth after FSS
- •(4) ECOG performance status (PS) of 0 or 1
- •(5) Measurable disease or non-measurable disease
- •(6) No prior treatment with irradiation or chemotherapy for any malignancy.
- •(7) Adequate organ functions with the latest examination within 14 days before registration
- •(8) No abnormal finding to need treatment on 12-lead ECG within 28 days before registration
- •(9) Written informed consent by the patient of 20 years or older. Written informed consent by both of the patient and the parent, if the patient is under 20 years old
排除标准
- •(1) Synchronous or metachronous (within 5 years) double malignancies
- •(2) Active systemic infections to be treated.
- •(3) Body temperature of 38 or more degrees Celsius
- •(4) Women during pregnancy, possible pregnancy, or breast-feeding
- •(5) Psychiatric disease difficult to participate in this clinical study
- •(6) Continuous systemic steroid treatment
- •(7) Uncontrolled diabetes mellitus or routine administration of insulin
- •(8) Uncontrolled hypertension
- •(9) Unstable angina (onset or worse heart attack of angina within 3 weeks) or prior myocardial infarction with in 6 months
- •(10) HBs antigen positive, HCV antibody positive, HIV antibody positive
- •(11) Interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema
- •(12) hypersensitivity to polyoxyethylated castor oil
- •(13) hypersensitivity to alcohol
研究者
相似试验
进行中（未招募）
3 期
JCOG1402: Non-randimized confirmatory trial of postoperative concurrent chemoradiotherapy (CCRT) using IMRT for patients with high-risk uterine cervical cancerPostoperative uterine cervical cancer patients with high-risk prognostic factorsJPRN-jRCTs031180194Toita Takafumi220
招募中
3 期
JCOG1315C: Non-randomized controlled study comparing proton beam therapy and hepatectomy for resectable hepatocellular carcinomaresectable hepatocellular carcinomaJPRN-jRCT1032180197Akimoto Tetsuo320
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 cancerendometrial cancer with preoperative risk of lymph node metastasis (preoperative stage IB-IIIC1)JPRN-jRCTs031180269WATARI Hidemichi590
招募中
3 期
JCOG1801: A phase III randomized controlled trial comparing surgery plus adjuvant chemotherapy with preoperative chemoradiotherapy followed by surgery plus adjuvant chemotherapy for locally recurrent rectal cancerresectable locally recurrent rectal cancerJPRN-jRCTs031190076Ito Masaaki110
招募中
3 期
JCOG2206: A randomized controlled phase III study comparing surgery alone versus adjuvant nivolumab versus adjuvant S-1 for locally advanced esophageal squamous cell carcinoma with no pathological complete response after neoadjuvant chemotherapy followed by curative esophagectomyEsophageal squamous cell carcinoma with no pathological complete response after neoadjuvant therapyJPRN-jRCTs031230219KITAGAWA Yuko450