Clinical trial NCT05197933: Safety of Laparoscopic Resection for Gastrointestinal Stromal Tumor on Unfavorable Anatomic Site of Stomach
Official title: Safety of Laparoscopic Resection for Gastrointestinal Stromal Tumor on Unfavorable Anatomic Site of Stomach：a Multicenter Prospective Trial（CLASS-06）
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastrointestinal Stromal Tumors
Keywords: Gastrointestinal Stromal Tumors
Unfavorable Anatomic Site of Stomach
Laparoscopic Resection
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Nanfang Hospital, Southern Medical University
name: Peking University Cancer Hospital & Institute
name: Shanghai Zhongshan Hospital
name: The First Affiliated Hospital with Nanjing Medical University
name: Fujian Medical University Union Hospital
name: Peking University People's Hospital
name: Ruijin Hospital
name: Wuhan Union Hospital, China
name: West China Hospital
name: First Affiliated Hospital, Sun Yat-Sen University
name: Liaoning Cancer Hospital & Institute
name: Chinese PLA General Hospital
First posted: 2022-01-20
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, multicenter, open-label, single-arm
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 3-year disease-free survival rate (DFS)
timeFrame: until the date of first documented progression, assessed up to 3 years
Secondary outcomes:
measure: Success rate of laparoscopic surgery
timeFrame: postoperative 15 days
measure: Rate of intraoperative complication
timeFrame: intraoperative time
measure: Rate of Postoperative complication
timeFrame: postoperative 30 days, or the discharge day if hospitalization>30 days
measure: 3-year overall survival rate (OS)
timeFrame: until the date of first documented progression, assessed up to 3 years
measure: Postoperative recovery course（Time to start off-bed activities, bowel function, to restore liquid food and semi-liquid food）
timeFrame: postoperative 30 days, or the discharge day if hospitalization>30 days
measure: Postoperative recovery course（Highest Body Temperature）
timeFrame: postoperative 3 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji hospital
state: Shanghai
Study officials:
affiliation: RenJi Hospital
name: Hui Cao, Professor
role: STUDY_CHAIR
References: