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

Gastrointestinal Stromal Tumors Clinical Trial

Official title:

Safety of Laparoscopic Resection for Gastrointestinal Stromal Tumor on Unfavorable Anatomic Site of Stomach：a Multicenter Prospective Trial（CLASS-06）

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05197933
• Other study ID #: CLASS-06
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: September 30, 2025

Study information

• Verified date: January 2022
• Source: RenJi Hospital
• Contact: Hui Cao, Professor
• Phone: 13918141425
• Email: caohuishcn[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 182
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors

Intervention

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

Locations

Country	Name	City	State
China	Renji hospital	Shanghai	Shanghai

Sponsors (13)

Lead Sponsor

Collaborator

RenJi Hospital

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year disease-free survival rate (DFS)	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.	until the date of first documented progression, assessed up to 3 years
Secondary	Success rate of laparoscopic surgery	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: ?? Resection is completed by total laparoscopy (extra auxiliary incision is not required. Tumor is extracted through the extended trocar incision);?Tumor is completely resected without rupture which complys with the principle of tumor isolation;?No conversion from laparoscopy to laparotomy due to incidences that laparascopy can not complete, including hemorrhage, unresectable tumor etc;?Resected 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.	postoperative 15 days
Secondary	Rate of intraoperative complication	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.	intraoperative time
Secondary	Rate of Postoperative complication	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.	postoperative 30 days, or the discharge day if hospitalization>30 days
Secondary	3-year overall survival rate (OS)	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.	until the date of first documented progression, assessed up to 3 years
Secondary	Postoperative recovery course(Time to start off-bed activities, bowel function, to restore liquid food and semi-liquid food)	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 30 days, or the discharge day if hospitalization>30 days
Secondary	Postoperative recovery course(Highest Body Temperature)	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.	postoperative 3 days