JPRN-jRCTs031180194进行中（未招募）3 期
JCOG1402: Non-randomized confirmatory trial of postoperative concurrent chemoradiotherapy (CCRT) using IMRT for patients with high-risk uterine cervical cancer - PopCC IMRT-CCRT
Toita Takafumi0 个研究点目标入组 220 人开始时间: 2019年3月6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
- 220
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 <= 70age old（—）
- 性别
- Female
入选标准
- •1. Clinical stage IB1, IB2, IIA1, IIA2, IIB cervical cancer (FIGO 2008)
- •2. Histological findings of squamous cell carcinoma (keratinizing or non-keratinizing), adenocarcinoma (endocervical mucinous type, intestinal mucinous type or endometrial type), or adenosquamous carcinoma
- •3. Histologically confirmed positive pelvic lymph nodes and/or parametrial invasion.
- •4. No distant metastasis in chest to pelvic contrast enhanced CT within 56 days before surgery
- •5. In case with node dissection except pelvic lesion, there is no positive node in these lesions.
- •6. Radical hysterectomy is performed and the following (i) to (v) are fulfilled.
- •i) R0 resection
- •ii) Negative margin is confirmed by pathological findings.
- •iii) At least 20 lymph nodes dissection confirmed by pathological findings.
- •iv) Ligamentum cardinale is removed.
- •v) The cut length of paracolpium and vagina is 2cm or more.
- •7. Aged 20 to 70 years old
- •8. ECOG performance status of 0 or 1
- •9. Within 28 to 56 days after surgery
- •10. No following prior treatment
- •i) Surgery except for cervical conization or radical hysterectomy for uterine cervical cancer
- •ii) Surgery for lower abdominal or pelvic malignancy
- •iii)Radiation therapy to the pelvis or chemotherapy for other malignancies
- •11. Adequate organ functions
- •12. 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 or possible pregnancy, within 28 days after delivery, or during breast-feeding
- •5) Severe psychiatric disease
- •6) Continuous systemic steroid treatment
- •7) Insulin-dependent or uncontrolled diabetes mellitus
- •8) Uncontrolled hypertension
- •9) Unstable angina, or history of myocardial infarction within 6 months
- •10) HBs antigen or HCV antibody positive
- •11) HIV antibody positive
- •12) Interstitial pneumonitis, lung fibrosis or severe emphysema on chest CT
研究者
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