Efficacy of HIPEC in the Treatment of Locally Advanced Gastric Cancer After radIcal Gastrectomy With D2
NCT ID: NCT02356276
Last Updated: 2017-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
584 participants
INTERVENTIONAL
2015-05-11
2022-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In order to evaluate the survival benefit and safety of radical surgery and HIPEC followed by postoperative chemotherapy in local advanced gastric cancer, patients who fulfill the inclusion and exclusion criteria will be recruited in this study and randomized to two treatment groups (HIPEC group and control group). In HIPEC group, the patients undergo radical gastrectomy with D2 lymphadenectomy and HIPEC with paclitaxel and postoperative chemotherapy. Patients in the control group just undergo radical gastrectomy with D2 lymphadenectomy followed by postoperative chemotherapy. Patients in both groups receive 6-8 cycles of postoperative systemic chemotherapy (XELOX or SOX regimens) . Patients are followed up for 5 years and the survival outcome will be analyzed.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
HIPEC group
Postoperative hyperthermic intraperitoneal chemotherapy (HIPEC) is performed after radical surgery, followed by 6-8 cycles of systemic chemotherapy. The first HIPEC is conducted within 48 h after surgery: Paclitaxel 75 mg/m\^2, 43°C, 60min. The second HIPEC is performed after 24 hours of the first HIPEC. The regimens are Paclitaxel 100 mg/m\^2, 43°C, 60min.
Systemic chemotherapy (XELOX or SOX regimens):
XELOX regimen: Oxaliplatin: 130 mg/m\^2, IV, d1; Capecitabine: 1 g/m\^2 bid, days 1-14, every 3 weeks for a total of 6-8 cycles.
If XELOX regimen is not conducted in some collaborators, SOX regimen is also permitted. The regimen is Oxaliplatin: 130 mg/m\^2, IV, d1; S-1, 40-60 mg/m\^2 bid, po, day 1-14, every 3 weeks for a total of 6-8 cycles.
D2 lymphadenectomy
Hyperthermic Intraperitoneal Chemotherapy
The first HIPEC is conducted within 48 h after surgery: Normal saline 3000 -4000ml, Paclitaxel 75mg/m\^2, 43°C, 60min. The second HIPEC is performed after 24 hours of the first HIPEC. The regimens are Paclitaxel 100 mg/m\^2, 43°C, 60min.
Systemic chemotherapy (XELOX or SOX regimens)
XELOX regimen: Oxaliplatin: 130 mg/m\^2, IV, d1; Capecitabine: 1 g/m\^2 bid, days 1-14, every 3 weeks for a total of 6-8 cycles.
SOX regimen: Oxaliplatin: 130 mg/m\^2, IV, d1; S-1, 40 mg/m\^2 bid, po, day 1-14 (S-1: BSA \<1.25m\^2, 40mg bid, 1.25m\^2≤ BSA ≤1.5m\^2, 50mg bid, BSA\>1.5m\^2, 60 mg bid) bid, d1-14, po, every 3 weeks for a total of 6-8 cycles.
Control group
6-8 cycles of systemic chemotherapy (XELOX or SOX regimens) were performed after radical gastrectomy with D2 lymphadenectomy.
XELOX regimen is Oxaliplatin: 130 mg/m\^2, IV, d1; Capecitabine: 1 g/m\^2 bid, days 1-14, every 3 weeks for a total of 6-8 cycles.
If XELOX regimen is not conducted in some collaborators, SOX regimen as comment systemic chemotherapy in Asia is also permitted to treat the patients. The treatment bundles are listed as follows: Oxaliplatin: 130 mg/m\^2, IV, d1; S-1, 40-60 mg/m\^2 bid (S-1: BSA \<1.25m\^2, 40mg bid, 1.25m\^2≤ BSA ≤1.5m\^2, 50mg bid, BSA\>1.5m\^2, 60 mg bid), po, day 1-14, every 3 weeks for a total of 6-8 cycles.
D2 lymphadenectomy
Systemic chemotherapy (XELOX or SOX regimens)
XELOX regimen: Oxaliplatin: 130 mg/m\^2, IV, d1; Capecitabine: 1 g/m\^2 bid, days 1-14, every 3 weeks for a total of 6-8 cycles.
SOX regimen: Oxaliplatin: 130 mg/m\^2, IV, d1; S-1, 40 mg/m\^2 bid, po, day 1-14 (S-1: BSA \<1.25m\^2, 40mg bid, 1.25m\^2≤ BSA ≤1.5m\^2, 50mg bid, BSA\>1.5m\^2, 60 mg bid) bid, d1-14, po, every 3 weeks for a total of 6-8 cycles.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
D2 lymphadenectomy
Hyperthermic Intraperitoneal Chemotherapy
The first HIPEC is conducted within 48 h after surgery: Normal saline 3000 -4000ml, Paclitaxel 75mg/m\^2, 43°C, 60min. The second HIPEC is performed after 24 hours of the first HIPEC. The regimens are Paclitaxel 100 mg/m\^2, 43°C, 60min.
Systemic chemotherapy (XELOX or SOX regimens)
XELOX regimen: Oxaliplatin: 130 mg/m\^2, IV, d1; Capecitabine: 1 g/m\^2 bid, days 1-14, every 3 weeks for a total of 6-8 cycles.
SOX regimen: Oxaliplatin: 130 mg/m\^2, IV, d1; S-1, 40 mg/m\^2 bid, po, day 1-14 (S-1: BSA \<1.25m\^2, 40mg bid, 1.25m\^2≤ BSA ≤1.5m\^2, 50mg bid, BSA\>1.5m\^2, 60 mg bid) bid, d1-14, po, every 3 weeks for a total of 6-8 cycles.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Male or Non pregnant female
* The Eastern Cooperative Oncology Group (ECOG) status 0-1
* T3 or T4 gastric adenocarcinoma (visual determination according to AJCC 2010 7th edition)
* No distance metastasis, eligible for D2 lymphadenectomy
* Have not received cytotoxic chemotherapy, radiotherapy or immunotherapy
* White blood cells \> 4,000/mm3
* neutrophils ≥ 1,500/mm3
* platelets ≥ 100,000/mm3
* hemoglobin\>9g/l
* Alanine transaminase (ALT) and aspartate aminotransferase (AST) \< or = 2.5 times upper limit of nominal (ULN)
* total bilirubin (TBIL) \< 1.5 times ULN
* serum creatinine \< 1 times ULN
* Having given written informed consent prior to any procedure related to the study
Exclusion Criteria
* Existence of distance metastasis during surgey (M1)
* Prior malignant tumors with detectable signs of recurrence or distant metastasis
* Poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac insufficiency, persistent hypertension despite medicinal treatment, ejection fraction\<50%
* Epileptic seizures patients need medicine control
* Uncontroled mental disease or mental disorder
* Drug abuse or psychological or social factors affect the judgment of results
* Contraindication to any therapy contained in this regimen specific to the study
* Receiving other chemotherapy, radiotherapy or immunotherapy
* Without given written informed consent
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tianjin Medical University Cancer Institute and Hospital
OTHER
Nanfang Hospital, Southern Medical University
OTHER
Zhejiang Cancer Hospital
OTHER
The Second Hospital of Hebei Medical University
OTHER
Chinese PLA General Hospital
OTHER
Henan Cancer Hospital
OTHER_GOV
Harbin Medical University
OTHER
Central South University
OTHER
Guangdong Provincial People's Hospital
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Sun Yat-sen University
OTHER
Hebei Medical University Fourth Hospital
OTHER
Guangdong Provincial Hospital of Traditional Chinese Medicine
OTHER
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
shuzhong cui, M.D
Role: STUDY_DIRECTOR
Affiliated Tumor Hospital of Guangzhou Medical University Recruiting
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Guangdong General Hospital
Guangzhou, Guangdong, China
Affiliated Tumor Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Wuhan Union Hospital, China
Wuhan, Hubei, China
The second Xiangya Hospital of Central South University
Changsha, Hunan, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Zhejiang Cancer Hospital
Hanzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Zheng Peng, M.D
Role: primary
Zhi-Wei Zhou, M.D
Role: primary
Xiao-Xi Zhu, M.B
Role: backup
Yong Li, M.D
Role: primary
Ze-Jian Lv, M.M
Role: backup
shuzhong cui, M.D
Role: primary
Zhen Tang, M.M
Role: backup
Jin Wang, M.D
Role: primary
Wen-Jun Xiong, M.M
Role: backup
Guo-Xin Li, M.D
Role: primary
Hao Liu, M.D
Role: backup
Bao-Jun Zhou, M.M
Role: primary
Shao-Wei Ma, M.M
Role: backup
Yong Li, M.D
Role: primary
Qing-Wei Liu, M.M
Role: backup
Kuan Wang, M.D
Role: primary
Guan-Yu Zhu, M.D
Role: backup
Guang-Sen Han
Role: primary
Wei Yang, M.M
Role: backup
Kai-Xiong Tao, M.D
Role: primary
Ke Wu, M.D
Role: backup
Hong-Liang Yao, M.D
Role: primary
San-Lin Lei, M.D
Role: backup
Han Liang, M.M
Role: primary
Xue-Jun Wang, M.D
Role: backup
Xin-Bao Wang, M.D
Role: primary
Chao Hu, M.D
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HIPEC-01
Identifier Type: -
Identifier Source: org_study_id