ClinicalTrials.gov

History of Changes for Study: NCT05871099
Laparoscopic Gastrectomy With D2 Lymphadenectomy Combined With Hyperthermic Intraperitoneal Chemotherapy (HIPEC) or Not
Latest version (submitted May 14, 2023) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 May 14, 2023 None (earliest Version on record)
Comparison Format:

Scroll up to access the controls

Study NCT05871099
Submitted Date:  May 14, 2023 (v1)

Open or close this module Study Identification
Unique Protocol ID: HIPEC-09
Brief Title: Laparoscopic Gastrectomy With D2 Lymphadenectomy Combined With Hyperthermic Intraperitoneal Chemotherapy (HIPEC) or Not
Official Title: Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Gastric Cancer After Laparoscopic Gastrectomy With D2 Lymphadenectomy: A Phase III Multicenter Prospective Randomized Controlled Clinical Trial
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2023
Overall Status: Recruiting
Study Start: November 20, 2022
Primary Completion: November 20, 2024 [Anticipated]
Study Completion: November 20, 2039 [Anticipated]
First Submitted: May 14, 2023
First Submitted that
Met QC Criteria:
May 14, 2023
First Posted: May 23, 2023 [Actual]
Last Update Submitted that
Met QC Criteria:
May 14, 2023
Last Update Posted: May 23, 2023 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: The Affiliated Hospital of Qingdao University
Responsible Party: Sponsor
Collaborators: Shandong Cancer Hospital Affiliated to Shandong First Medical University
Chinese PLA General Hospital
Zibo Central Hospital
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Jinan Central Hospital
Qilu Hospital of Shandong University
Yantai Yuhuangding Hospital
Nanfang Hospital, Southern Medical University
Provincial Hospital Affiliated to Shandong First Medical University
The First Affiliated Hospital of Nanchang University
The Fourth Hospital of Hebei Medical University
Peking University Cancer Hospital & Institute
Peking University People's Hospital
Tianjin Cancer Hospital
First Affiliated Hospital of Xi 'an Jiaotong University
Union Hospital of Huazhong University of Science and Technology
Wuhan University
Brigham and Women's Hospital
The Second Xiangya College of Central South University
Weihai Municipal Hospital
Mountain University Cancer Hospital
Ruijin Hospital
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The goal of this clinical trial is to learn about Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Gastric Cancer after Laparoscopic Gastrectomy with D2 Lymphadenectomy. The main question it aims to answer is: whether HIPEC can effectively improving the 5-year overall survival rate and decrease the peritoneal metastases rate of patients with advanced gastric cancer underwent Laparoscopic Gastrectomy with D2 Lymphadenectomy. Participants will be divided into two groups, Experimental group received laparoscopic (robotic) D2 surgery plus HIPEC2 times plus systemic chemotherapy 6~8 cycles; and Control group received laparoscopic (robotic) D2 surgery plus systemic chemotherapy 6~8 cycles.
Detailed Description:
Open or close this module Conditions
Conditions: Gastric Cancer
Keywords: Advanced Gastric Cancer
HIPEC
Laparoscopic Gastrectomy
Randomized Clinical Trial
Recurrence-free survival
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 616 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Experimental group
Experimental group receive laparoscopic (robotic) D2 surgery plus HIPEC2 times plus systemic chemotherapy 6~8 cycles.
Procedure: Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Experimental group receive HIPEC two times after laproscopic gastrectomy
No Intervention: Control group
Control group receive laparoscopic (robotic) D2 surgery + systemic chemotherapy 6-8 cycles
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 5-years Recurrence-free survival
[ Time Frame: 5 years ]

Secondary Outcome Measures:
1. 5-year overall survival rate
[ Time Frame: 5 years ]

2. peritoneal metastasis rate
[ Time Frame: 5 years ]

3. peritoneal metastasis-free survival
[ Time Frame: 5 years ]

4. Regional recurrence rate
[ Time Frame: 5 years ]

local recurrence after radical gastrectomy refers to the recurrence of anastomosis, duodenal stump, tumor bed, and residual stomach, including the recurrence of regional lymph nodes
5. distant metastasis rate
[ Time Frame: 5 years ]

6. Toxic and side effects of the program
[ Time Frame: 5 years ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 80 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

(1) Newly treated patients who did not receive chemotherapy, radiotherapy or other antitumor therapy before the start of the clinical trial;(2) Aged 18-80 years;(3) male or non-pregnant or lactating female;(4) Gastric adenocarcinoma was pathologically confirmed, and laparoscopic (robotic) radical gastrectomy was planned;(5) Patients with T stage T3 or above, no distant metastasis, and feasible criteria for laparoscopic D2 radical resection (AJCC Eighth edition);(6) The estimated survival time is more than 6 months;(7) History of nonabdominal surgery (except laparoscopic cholecystectomy);(8) The bone marrow reserve function was good, and the blood routine met the following conditions: white blood cell count ≥3.5×109/L, neutrophil ≥1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥90g/L;(9) Organ function was good, and biochemical examination met the following conditions: ALT≤2.5× upper limit of normal value (ULN), AST≤2.5×ULN, serum total bilirubin ≤1.5×ULN, serum creatinine ≤1.5×ULN;(10) Functional status: 0-1 (ECOG);(11) Preoperative ASA grade I-III;(12) Voluntarily sign the informed consent.

Exclusion Criteria:

(1) Lymph node BulkyN2 status was diagnosed by abdominal CT/MRI, that is, at least one lymph node meridian ≥3cm or three consecutive lymph nodes, each meridian ≥1.5cm;(2) pregnant or lactating women;(3) Other malignant tumors within 5 years;(4) Preoperative temperature ≥38℃ or complicated with infectious diseases requiring systematic treatment;(5) serious mental illness;(6) Severe respiratory diseases, FEV1< 50%;(7) Severe liver and kidney dysfunction, liver enzyme elevation more than 2 times the normal value;(8) History of unstable angina pectoris or myocardial infarction within 6 months;(9) History of cerebral infarction or cerebral hemorrhage within 6 months, except old infarct;(10) Systemic glucocorticoid therapy within 1 month;(11) Patients with gastric cancer complications (bleeding, perforation, obstruction) requiring emergency surgery;(12) The patient has participated in or is currently participating in other clinical studies (within 6 months);(13) Laparoscopic exploration, biopsy and cytology confirmed intraperitoneal implantation and metastasis.

Open or close this module Contacts/Locations
Central Contact Person: Yanbing Zhou, MD
Telephone: 86532-82911324
Email: zhouyanbing@qduhospital.cn
Central Contact Backup: Xiaodong Liu, MD
Telephone: 86532-82911324
Email: miaozilxd@163.com
Study Officials: Yanbing Zhou, MD
Study Director
The Affiliated Hospital of Qingdao University
Locations: China, Shandong
The Affiliated Hospital of Qingdao University
[Recruiting]
Qingdao, Shandong, China
Contact:Contact: Xiaodong Liu, MD 86532-82911324 miaozilxd@163.com
Open or close this module IPDSharing
Plan to Share IPD: Yes
Supporting Information:
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame:
Access Criteria:
URL:
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services