JPRN-jRCTs031180177已完成2 期
JCOG1207: A randomized controlled phase II/III study comparing EBD combined with steroid versus RIC combined with steroid for refractory anastomotic stricture after esophagectomy - RICS study
MUTO Manabu0 个研究点目标入组 130 人开始时间: 2019年3月5日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 130
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 ot applicable（—）
- 性别
- All
入选标准
- •1 st inclusion criteria
- •1) Meet all the following criteria about surgery for esophageal cancer:
- •a) Subtotal esophagectomy for thoracic esophageal cancer performed.
- •b) No finding of recurrence.
- •c) Gastric tube reconstruction.
- •d) No residual tumor.
- •2) Endoscopic balloon dilation (EBD) or bougienage for anastomotic stricture was performed more than twice for 24 weeks. If dilations were performed twice or more within 6 days , dilation was counted as once.
- •3) Dysphagia score >=2.
- •4) Stricture length <=2cm diagnosed by endoscopy or X-ray fluoroscopy.
- •5) No postoperative chemotherapy for esophageal cancer within 28 days before registration.
- •6) No prior history of radiotherapy for recurrence after esophagectomy or preoperative radiotherapy more than 60 Gy.
- •7) No prior history of chemotherapy for any cancer within 28 days before registration, and
- •no plan of chemotherapy within 24 weeks after registration.
- •8) Age>=20
- •9) Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •10) Sufficient organ function
- •11) Written informed consent
- •2 nd inclusion criteria
- •i) At any point after the last dilatation, the presence of anastomotic stricture was confirmed by endoscopic examination performed within 28 days before second registration.
- •ii) The presence of anastomotic stricture is defined as the situation that endoscope (diameter, 9.6 mm-10.4 mm) does not pass through the anastomotic stricture. Pinhole stricture which a device for dilatation or RIC cannot pass through is ineligible.
排除标准
- •1) Active infection requiring systemic therapy
- •2) Body temperature >=38 degrees Celsius
- •3) Pregnancy, possible pregnancy within 28 days after delivery or breastfeeding
- •4) Psychiatric disease
- •5) Patients requiring systemic steroid medication
- •6) Patients requiring continuous anticoagulant or antiplatelet drug
- •7) Poorly controlled hypertension
- •8) Unstable angina within 3 weeks, or with a history of myocardial infarction within 6 months
研究者
相似试验
招募中
3 期
JCOG2207: A phase III randomized controlled trial comparing total mesorectal excision and lateral lymph node dissection plus adjuvant chemotherapy with total neoadjuvant therapy followed by total mesorectal excision and selective lateral lymph node dissection for the patients with locoregionally advanced low rectal cancerRectal cancerJPRN-jRCTs031230415OHUE Masayuki420
招募中
2 期
JCOG2203: A randomized controlled phase II/III trial of neoadjuvant chemotherapy for Japanese patients with esophagogastric junction adenocarcinomaJPRN-jRCTs031230182KUROKAWA Yukinori460
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
进行中（未招募）
3 期
JCOG1109: A randomized controlled phase III comparing CF versus DCF versus CF-RT as neoadjuvant treatment for locally advanced esophageal cancerclinical stage IB/II/III thoracic esophageal cancerJPRN-jRCTs031180202Kato Ken600
进行中（未招募）
3 期
JCOG1314: A randomized controlled phase III study comparing docetaxel, CDDP and 5-FU with CDDP and 5-FU in patients with metastatic or recurrent esophageal canceresophageal cancerJPRN-jRCTs031180143TSUBOSA Yasuhiro240