Gastrointestinal Stromal TumorsNCT05197933
Safety of Laparoscopic Resection for Gastrointestinal Stromal Tumor on Unfavorable Anatomic Site of Stomach
A study testing Laparoscopic resection in people with Gastrointestinal Stromal Tumors, run by RenJi Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastrointestinal Stromal Tumors
- What is being tested?
- Laparoscopic resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji hospital
Shanghai, Shanghai Municipality, 200127
Hui Cao, Professor, 13918141425, caohuishcn@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastrointestinal Stromal Tumors
- Being tested
- Laparoscopic resection
- Keywords
- Gastrointestinal Stromal Tumors, Unfavorable Anatomic Site of Stomach, Laparoscopic Resection
- Medical subject headings
- Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic resectionProcedure or surgery
Laparoscopic resection for GIST at unfavorable anatomic site of stomach will be conducted
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic resection | Experimental | laparoscopic resection for GIST at unfavorable anatomic sites of stomach Receives: Procedure: Laparoscopic resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: until the date of first documented progression, assessed up to 3 years
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: postoperative 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start1 Oct 2020
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Stromal TumorsStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, multicenter, open-label, single-arm
- Masking
- None (open label)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- 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, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, West China Hospital, First Affiliated Hospital, Sun Yat-Sen University, Liaoning Cancer Hospital & Institute, Chinese PLA General Hospital
- Responsible party
- Principal investigator, Hui Cao, RenJi Hospital
- Investigators
- Hui Cao, Professor, Study chair, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197933
- Sponsor's protocol ID
- CLASS-06
- Status last verified
- Jan 2022
- First submitted
- 7 Sep 2021
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Laparoscopic Resection for Gastrointestinal Stromal Tumor on Unfavorable Anatomic Site of Stomach：a Multicenter Prospective Trial（CLASS-06）
- ClinicalTrials.gov ID
- NCT05197933
- Acronym / sponsor ID
- CLASS-06
- Conditions
- Gastrointestinal Stromal Tumors
- Keywords
- Gastrointestinal Stromal Tumors, Unfavorable Anatomic Site of Stomach, Laparoscopic Resection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- 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, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, West China Hospital, First Affiliated Hospital, Sun Yat-Sen University, Liaoning Cancer Hospital & Institute, Chinese PLA General Hospital
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, multicenter, open-label, single-arm
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic resection | Experimental | Procedure: Laparoscopic resectionlaparoscopic resection for GIST at unfavorable anatomic sites of stomach |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (23 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic resectionLaparoscopic resection for GIST at unfavorable anatomic site of stomach will be conducted | Procedure or surgery | Laparoscopic resection |
Primary outcome
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.
6 secondary outcomes
Success rate of laparoscopic surgery
Time frame: postoperative 15 days
Rate of intraoperative complication
Time frame: intraoperative time
Rate of Postoperative complication
Time frame: postoperative 30 days, or the discharge day if hospitalization>30 days
3-year overall survival rate (OS)
Time frame: 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 frame: postoperative 30 days, or the discharge day if hospitalization>30 days
Postoperative recovery course（Highest Body Temperature）
Time frame: postoperative 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui Cao, Professor study chair
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic resection in people with Gastrointestinal Stromal Tumors, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui Cao, Professor (13918141425, caohuishcn@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year disease-free survival rate (DFS) (time frame: until the date of first documented progression, assessed up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2022.