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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gastrointestinal Stromal Tumors
• Intervention / Treatment: Procedure: Laparoscopic resection

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
• Enrollment (Anticipated): 182
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Recruiting
      • Renji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laparoscopic resection; laparoscopic resection for GIST at unfavorable anatomic sites of stomach	Procedure: Laparoscopic resection; Laparoscopic resection for GIST at unfavorable anatomic site of stomach will be conducted

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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： 。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.	postoperative 15 days
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
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
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
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): September 30, 2025
• Study Completion (Anticipated): September 30, 2025

Study Registration Dates

• First Submitted: September 7, 2021
• First Submitted That Met QC Criteria: January 14, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): January 20, 2022
• Last Update Submitted That Met QC Criteria: January 14, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Laparoscopic Resection; Gastrointestinal Stromal Tumors; Unfavorable Anatomic Site of Stomach
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Neoplasms, Connective Tissue; Gastrointestinal Stromal Tumors
• Other Study ID Numbers: CLASS-06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No