JPRN-jRCTs031180167已完成3 期
JCOG1101: Nonrandomized confirmatory trial of modified radical hysterectomy for patients with FIGO stage Ib1 (< 2 cm) uterine cervical cancer - CC-MoRH
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
研究概览
简要总结
Modified radical hysterectomy (MRH) was as effective as radical hysterectomy and less invasive. MRH can be considered a standard surgery for tumor diameter <= 2 cm Stage IB1 uterine cervical cancer.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 70age old（—）
- 性别
- All
入选标准
- •1) Any one of the following histology in primary lesion located at uterine cervix.
- •i) Squamous cell carcinoma (keratinizing or nonkeratinizing type)
- •ii) Adenosquamous carcinoma (except for glassy cell carcinoma)
- •iii) Adenocarcinoma (endocervical type mucinous adenocarcinoma, intestinal type mucinous adenocarcinoma, or endometrioid adenocarcinoma)
- •2) To fulfill i) or ii) in clinical stage IB1 (The General Rules for Clinical and Pathological Management of Uterine Cervical Cancer, the 3rd edition, 2012)
- •i) When tumor is detected in pelvic MRI within 56 days before registration and its maximum diameter is 2cm or less, (a) or (b) are fulfilled
- •(a) In case with diagnostic conization of the cervix within 49 days before registration, the maximum length of invasive tumor is 2 cm or less with the diagnostic conization
- •(b) In case without diagnostic conization of the cervix, invasive tumor is not detected or length of invasive tumor is 2 cm or less in colposcopy within 56 days before registration
- •ii) When tumor is not detected in pelvic MRI within 56 days before registration, (a) or (b) are fulfilled
- •(a) When invasive tumor is not detected in colposcopy within 56 days before registration, the maximum length of invasive tumor is 2 cm or less with diagnostic conization of the cervix within 49 days before registration
- •(b) Invasive tumor is detected and the maximum length of the tumor is 2 cm or less in colposcopy within 56 days before registration
- •3) Neither distant lymph node metastasis nor distant metastasis in abdominal and pelvic computed tomography within 56 days before registration
- •4) Aged 20 to 70 years old
- •5) ECOG performance status (PS) of 0 or 1
- •6) No following prior treatment
- •i) Surgery except for cervical conization for uterine cervical cancer
- •ii) Surgery for lower abdominal or pelvic malignancy
- •iii) Radiation therapy or chemotherapy for other malignancies
- •7) Adequate organ functions
- •8) Written informed consent
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 or more degrees Celsius
- •4) Women during pregnancy, possible pregnancy, or breast-feeding
- •5) Psychiatric disease
- •6) Continuous systemic steroid treatment
- •7) Uncontrolled diabetes mellitus or routine administration of insulin
- •8) Uncontrolled hypertension
研究者
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