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Trial record 4 of 350 for:    Gastrointestinal Stromal Tumors
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Safety of Laparoscopic Resection for Gastrointestinal Stromal Tumor on Unfavorable Anatomic Site of Stomach

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ClinicalTrials.gov Identifier: NCT05197933
Recruitment Status : Recruiting
First Posted : January 20, 2022
Last Update Posted : January 20, 2022
Sponsor:
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Stromal Tumors Procedure: Laparoscopic resection Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 182 participants
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
Official Title: Safety of Laparoscopic Resection for Gastrointestinal Stromal Tumor on Unfavorable Anatomic Site of Stomach：a Multicenter Prospective Trial（CLASS-06）
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : September 30, 2025
Estimated Study Completion Date : September 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05197933


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

Locations
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China, Shanghai
Renji hospital Recruiting
Shanghai, Shanghai, China, 200127
Contact: Hui Cao, Professor    13918141425    caohuishcn@hotmail.com   
Sponsors and Collaborators
RenJi Hospital
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
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Study Chair: Hui Cao, Professor RenJi Hospital
  Study Documents (Full-Text)

Documents provided by Hui Cao, RenJi Hospital:
Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] July 1, 2021

More Information
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Responsible Party: Hui Cao, Professor, RenJi Hospital
ClinicalTrials.gov Identifier: NCT05197933    
Other Study ID Numbers: CLASS-06
First Posted: January 20, 2022    Key Record Dates
Last Update Posted: January 20, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hui Cao, RenJi Hospital:
Gastrointestinal Stromal Tumors
Unfavorable Anatomic Site of Stomach
Laparoscopic Resection
Additional relevant MeSH terms:
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Gastrointestinal Stromal Tumors
Neoplasms
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
 Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases