NCT05197933招募中不适用
Safety of Laparoscopic Resection for Gastrointestinal Stromal Tumor on Unfavorable Anatomic Site of Stomach：a Multicenter Prospective Trial（CLASS-06）
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- 3-year disease-free survival rate (DFS)
研究概览
简要总结
The aim of this trial is to evaluate the safety of laparoscopic resection for GIST whose diameter is ≥2cm and ≤5cm at unfavorable anatomic sites of stomach.
详细描述
The aim of this trial is to evaluate the safety of laparoscopic resection for GIST whose diameter is ≥2cm and ≤5cm at unfavorable anatomic sites of stomach. Unfavorable anatomic sites are defined by soft tissue sarcoma, NCCN Clinical Practice Guidelines in Oncology (version 2. 2018). The defined laparoscopy unfavorable sites including the anatomic sites of stomach other than greater curvature and front wall, including the less curvature, the posterior wall, and adjacent to cardia and pylorus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Blinding Method: Open Label
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from over 18 to under 75 years;
- •Gastrointestinal stromal tumor at unfavorable anatomic sites of stomach preoperatively confirmed by endoscopy, ultrasound endoscopy, CT or MRI;
- •Diameter of tumor size is ≥2cm and ≤5cm confirmed by contrast CT or MRI;
- •Patients whose tumor is resectable by laparoscopic technique at preoperative assessment;
- •No evidence of distant metastasis and tumor invading nearby organs at preoperative assessment;
- •Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale;
- •ASA (American Society of Anesthesiology) score I, II, or III;
- •Written informed consent.
排除标准
- •Women during pregnancy or breast-feeding;
- •Severe mental disorder;
- •History of previous upper abdominal surgery (except laparoscopic cholecystectomy);
- •History of other malignant disease within the past five years;
- •History of previous neoadjuvant imatinib therapy;
- •History of unstable angina or myocardial infarction within the past six months;
- •History of cerebrovascular accident within the past six months;
- •History of continuous systematic administration of corticosteroids within the past month;
- •Requirement of simultaneous surgery for other disease;
- •Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastrointestinal stromal tumor;
- •FEV1<50% of predicted value;
- •Patients with GIST locates at favorable anatomic sites detected by contrast CT, MRI or ultrasound endoscopy at preoperative assessment;
- •Patients with GIST diameter<2cm or>5cm detected by contrast CT or MRI;
- •Presence of distant metastasis or tumor invading nearby organs at preoperative assessment.
- •Withdrawal Criteria:
- •Patients postoperatively confirmed as non-GIST case by pathology (These cases are enrolled in safe group for future statistic analysis);
- •GIST at unfavorable anatomic site diagnosed before operation, while GIST at favorable anatomic site determined by intraoperative exploration;
- •Patients confirmed as tumor rupture , metastasis or invading nearby organs intraoperately;
- •Patients requiring simultaneous surgical treatment of other diseases;
- •Sudden severe complications during the perioperative period (intolerable surgery or anesthesia), which renders it unsuitable or unfeasible to implement the study treatment protocol as scheduled;
- •Patients confirmed to require emergency surgery by attending physicians due to changes in the patient's condition after inclusion in this study;
- •Patients who voluntarily quit or discontinue treatment for personal reasons at any stage after inclusion in this study;
- •Treatment implemented is proven to violate study protocol.
结局指标
主要结局
3-year disease-free survival rate (DFS)
时间窗: until the date of first documented progression, assessed up to 3 years
The number of patients with DFS \> 3 years was used as the numerator and the number of all patients was used as the denominator to calculate the ratio value.
次要结局
- Success rate of laparoscopic surgery(postoperative 15 days)
- Rate of intraoperative complication(intraoperative time)
- Rate of Postoperative complication(postoperative 30 days, or the discharge day if hospitalization>30 days)
- 3-year overall survival rate (OS)(until the date of first documented progression, assessed up to 3 years)
- Postoperative recovery course（Time to start off-bed activities, bowel function, to restore liquid food and semi-liquid food）(postoperative 30 days, or the discharge day if hospitalization>30 days)
- Postoperative recovery course（Highest Body Temperature）(postoperative 3 days)
研究者
研究点 (1)
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