Safety of Laparoscopic Resection for Gastrointestinal Stromal Tumor on Unfavorable Anatomic Site of Stomach

• ClinicalTrials.gov Identifier: NCT05197933
• Recruitment Status: Recruiting
• First Posted: January 20, 2022
• Last Update Posted: January 20, 2022
• Sponsor: RenJi Hospital
• Collaborators: Nanfang Hospital, Southern Medical University; Peking University Cancer Hospital & Institute; Shanghai Zhongshan Hospital; The First Affiliated Hospital with Nanjing Medical University; Fujian Medical University Union Hospital; Peking University People's Hospital; Ruijin Hospital; Wuhan Union Hospital, China; West China Hospital; First Affiliated Hospital, Sun Yat-Sen University; Liaoning Cancer Hospital & Institute; Chinese PLA General Hospital
• Information provided by (Responsible Party): Hui Cao, RenJi Hospital

Tracking Information

• First Submitted Date: September 7, 2021
• First Posted Date: January 20, 2022
• Last Update Posted Date: January 20, 2022
• Actual Study Start Date: October 1, 2020
• Estimated Primary Completion Date: September 30, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 14, 2022)

3-year disease-free survival rate (DFS) [ Time Frame: 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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: January 14, 2022)

• Success rate of laparoscopic surgery [ Time Frame: postoperative 15 days ]
  The proportion value will be calculated for the number of patients receiving laparoscopic local resection for GIST locating at unfavorable sites of stomach and meet the following 4 criteria as the numerator and the number of all patient undergo surgical treatment (laparoscopic surgery/laparotomy) as the denominator. Definition of successful laparoscopic resection： 。① Resection is completed by total laparoscopy (extra auxiliary incision is not required. Tumor is extracted through the extended trocar incision)；②Tumor is completely resected without rupture which complys with the principle of tumor isolation；③No conversion from laparoscopy to laparotomy due to incidences that laparascopy can not complete, including hemorrhage, unresectable tumor etc；④Resected margin confirmed to be negative by postoperative pathology. All the previous 4 criteria have to be achieved simultaneously to be considered a complete laparoscopic surgery.
• Rate of intraoperative complication [ Time Frame: intraoperative time ]
  The proportion value will be calculated for the number of patients with any intraoperative complication as the numerator and the number of all patients undergoing surgical treatment (laparoscopic surgery/laparotomy) as the denominator.
• Rate of Postoperative complication [ Time Frame: postoperative 30 days, or the discharge day if hospitalization>30 days ]
  The proportion value will be calculated for the number of patients with any postoperative complication as the numerator and the number of all patients undergoing surgical treatment (laparoscopic surgery/laparotomy) as the denominator.
• 3-year overall survival rate (OS) [ Time Frame: until the date of first documented progression, assessed up to 3 years ]
  The number of patients with OS > 3 years was used as the numerator and the number of all patients was used as the denominator to calculate the ratio value.
• Postoperative recovery course（Time to start off-bed activities, bowel function, to restore liquid food and semi-liquid food） [ Time Frame: postoperative 30 days, or the discharge day if hospitalization>30 days ]
  Time to start off-bed activities, bowel function, to restore liquid food and semi-liquid food

  • Starting from the postoperative day 1 to the first postoperative discharge, within the initial recognition of the earliest time for off-bed activities, bowel function (flatulence/bowel movement), to restoration of fluid/semi-fluid diet; records are made hourly.
  • Flatulence/bowel movement on the day of surgery is excluded.
  • In case of no off-bed activities/flatulence/bowel movement/restoration of liquid/semi-liquid diet before the first postoperative discharge, the discharge time should be recorded as the time of off-bed activities/flatulence/bowel movement/restoration of liquid/semi-liquid diet.
  • The initial time of off-bed activities/flatulence/bowel movement/restoration of liquid/semi-liquid diet is per patient report.
• Postoperative recovery course（Highest Body Temperature） [ Time Frame: postoperative 3 days ]
  Highest Body Temperature • The highest body temperature starting from postoperative day 1 up to day 3 should be measured at least three times a day.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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）
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Prospective, multicenter, open-label, single-arm

Masking: None (Open Label)
Masking Description:

Blinding Method: Open Label

Primary Purpose: Treatment

• Condition: Gastrointestinal Stromal Tumors

Intervention

Procedure: Laparoscopic resection

Laparoscopic resection for GIST at unfavorable anatomic site of stomach will be conducted

Study Arms

Experimental: Laparoscopic resection

laparoscopic resection for GIST at unfavorable anatomic sites of stomach

Intervention: Procedure: Laparoscopic resection

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 14, 2022): 182
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 30, 2025
• Estimated Primary Completion Date: September 30, 2025 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Hui Cao, Professor; 13918141425; caohuishcn@hotmail.com

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT05197933
• Other Study ID Numbers: CLASS-06
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Hui Cao, RenJi Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: RenJi Hospital
• Original Study Sponsor: Same as current

Collaborators

• Nanfang Hospital, Southern Medical University
• Peking University Cancer Hospital & Institute
• Shanghai Zhongshan Hospital
• The First Affiliated Hospital with Nanjing Medical University
• Fujian Medical University Union Hospital
• Peking University People's Hospital
• Ruijin Hospital
• Wuhan Union Hospital, China
• West China Hospital
• First Affiliated Hospital, Sun Yat-Sen University
• Liaoning Cancer Hospital & Institute
• Chinese PLA General Hospital

Investigators

• Study Chair: Hui Cao, Professor; RenJi Hospital

• PRS Account: RenJi Hospital
• Verification Date: January 2022