A Multicenter, RCT Study of the Clinical Efficacy of Robotic and Laparoscopic Gastrectomy in Neoadjuvant Gastric Cancer (CLASS14)
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ClinicalTrials.gov Identifier: NCT06042998 |
Recruitment Status :
Recruiting
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastric Cancer Stage II Gastric Cancer Stage III | Procedure: Robotic radical gastrectomy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 588 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Group A (experimental group): Performing robot radical gastrectomy Group B (control group): Performing laparoscopic radical gastrectomy |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Prospective, Multicenter, Randomized, Controlled Study of the Clinical Efficacy of Robotic and Laparoscopic Radical Gastrectomy in Neoadjuvant Gastric Cancer Patients |
Actual Study Start Date : | July 7, 2023 |
Estimated Primary Completion Date : | December 30, 2024 |
Estimated Study Completion Date : | December 30, 2027 |
Arm | Intervention/treatment |
---|---|
Experimental: Robotic group
Robotic gastrectomy
|
Procedure: Robotic radical gastrectomy
Laparoscopic gastrectomy
Other Name: Laparoscopic gastrectomy |
Active Comparator: Laparoscopic group
Laparoscopic gastrectomy
|
Procedure: Robotic radical gastrectomy
Laparoscopic gastrectomy
Other Name: Laparoscopic gastrectomy |
- 3-year disease-free survival [ Time Frame: three years after surgery ]3-year disease-free survival
- 3-year overall survival rate [ Time Frame: three years after surgery ]3-year overall survival rate
- overall postoperative morbidity rates [ Time Frame: 30 days after surgery ]overall postoperative morbidity rates
- postoperative recovery course [ Time Frame: 14 days surgery ]postoperative recovery course
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18 years old ≤ 75 years old male or female;
- The primary gastric lesion was diagnosed as gastric adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, Signet ring cell carcinoma, poorly differentiated adenocarcinoma) by endoscopic biopsy histopathology;
- Before neoadjuvant treatment, the preoperative clinical staging was confirmed to be II and III (cT2N+M0 or cT3-4a/N+M0) through gastroscopy/ultrasound gastroscopy, enhanced CT/MR, or diagnostic laparoscopic exploration (based on AJCC-8th TNM tumor staging);
- 2-4 cycles of neoadjuvant therapy (chemotherapy+/- targeted/immunotherapy, simple chemotherapy);
- After new adjuvant treatment, radical Gastrectomy is feasible after MDT discussion;
- Preoperative ECOG physical condition score of 0/1 or Karst score ≥ 70%;
- Preoperative ASA score I-III;
- The expected survival period exceeds 6 months;
- Willing and able to comply with the research protocol;
- Sign a written informed consent form before enrollment and be fully aware of the right to withdraw from this study at any time.
Exclusion Criteria:
- Pregnant or lactating women;
- Suffering from serious mental illness;
- History of upper abdominal surgery (excluding history of laparoscopic cholecystectomy);
- History of gastric surgery (excluding ESD/EMR for gastric cancer);
- Moderate to severe renal insufficiency;
- Organ transplant recipients receiving immunosuppressive therapy;
- Have a history of other malignant diseases within 5 years;
- Have a history of unstable angina or myocardial infarction within 6 months;
- Have a history of cerebral infarction or cerebral hemorrhage within 6 months;
- Have a history of continuous systemic corticosteroid therapy within one month;
- Simultaneous surgical treatment of other diseases is required (excluding laparoscopic cholecystectomy);
- Gastric cancer comorbidities (bleeding, perforation, obstruction) requiring emergency surgery;
- Lung function test FEV1<50% of expected value;
- The patient has participated or is currently participating in other clinical studies (within 6 months).
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): NCT06042998
Contact: Yanbing Zhou | 13708971773 | zhouyanbing999@aliyun.com |
China, Shandong | |
Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital | Recruiting |
Qingdao, Shandong, China, 266000 | |
Contact: Zhou Yanbing 86532-82911324 zhouyanbing@qduhospital.cn |
Responsible Party: | The Affiliated Hospital of Qingdao University |
ClinicalTrials.gov Identifier: | NCT06042998 |
Other Study ID Numbers: |
CLASS-14 |
First Posted: | September 21, 2023 Key Record Dates |
Last Update Posted: | September 21, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | Sharing data with participating centers |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Neoadjuvant therapy gastric cancer robot radical gastrectomy |
laparoscopic Gastrectomy short-term clinical outcome prognosis |
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |