Cytoreductive Surgery Combined With HIPEC and Chemotherapy for Gastric Cancer With Peritoneal Metastasis
1 other identifier
interventional
220
1 country
13
Brief Summary
This study evaluates the survival benefit and safety of cytoreductive surgery(CRS) combined with HIPEC and chemotherapy in gastric cancer with peritoneal metastasis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2016
Longer than P75 for phase_3
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 9, 2017
CompletedFirst Posted
Study publicly available on registry
January 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedSeptember 13, 2019
September 1, 2019
6.4 years
January 9, 2017
September 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
2-year Median survival time
The time point when the cumulative survival rate is 50% according to the survival curve.
24 months
Secondary Outcomes (3)
2-year overall survival rate
24 months
Progression free survival rate
24 months
Morbidity and mortality
30 days; 24 months
Other Outcomes (5)
Quality of life(site-specific module for gastric cancer)
Every 6 months to 2 years
Quality of life
Every 6 months to 2 years
circulating tumor cell（CTC） alteration
Every 6 months to 2 years
- +2 more other outcomes
Study Arms (1)
CRS + HIPEC + Systemic Chemotherapy
EXPERIMENTALCytoreductive surgery(CRS) followed by Hyperthermic Intraperitoneal Chemotherapy(HIPEC) and systemic chemotherapy will be performed for the treatment of patients assigned to this group. CF regimens or other first line regimens based on Fluoropyrimidine and Cisplatin according to the National Comprehensive Cancer Network（NCCN） Guidelines （Gastric Cancer，version 3.2016) are recommended.Regimens and dosing schedules are not limited in this trial.
Interventions
Gastrectomy with D2 lymph node dissection and Metastasectomy for peritoneal metastatic sites only. A total, distal, or proximal gastrectomy and the type of reconstruction will be selected according to the surgeon's experience. Metastasectomy is limited to peritoneal metastatic sites only to render the patient no evidence of disease (NED) with at least 1cm negative margins when possible.
Docetaxel 120 mg diluted in 5.0 L of saline is forced into the abdomen through the inflow catheter by a pump and pulled out through the drains as a heated intraperitoneal perfusion.A heat exchanger keeps the intraperitoneal fluid at 43±0.5℃ and duration limited to 70 minutes.24 hours after cytoreductive surgery no less than 2 cycles postoperative chemotherapy will be recommended.
CF regimens or other first line regimens based on Fluoropyrimidine and Platinum according to the NCCN Guidelines（Gastric Cancer，version 3.2016) are recommended.Regimens and dosing schedules are not limited in this trial.
CF regimens or other first line regimens based on Fluoropyrimidine and Platinum according to the NCCN Guidelines（Gastric Cancer，version 3.2016) are recommended.Regimens and dosing schedules are not limited in this trial.
Eligibility Criteria
You may qualify if:
- Age from over 18 to under 75 years
- Histologically proven primary gastric adenocarcinoma confirmed pathologically by endoscopic biopsy
- Diagnosed with clinical T1-4N0-3M1（distant metastases confined to peritoneum, P1）according to the American Joint Committee on Cancer(AJCC) Cancer Staging Manual Seventh Edition by laparoscopic exploration
- Localized peritoneal metastasis with peritoneal cancer index(PCI) less than 20
- Resection of primary tumor and metastasis is anticipated to reach the CC0 status(no residual tumor )
- Performance status of 0 or 1 on Eastern Cooperative Oncology Group(ECOG) scale
- Written informed consent
You may not qualify if:
- Adenocarcinoma of esophageal-gastric junction(AEG) that requires thoracotomy
- Distant metastases not confined to peritoneum, including liver (H1), para-aortic lymphnode (stations 16a1 and/or b2), lung, brain, bone and other organs
- Histologically proven Human epidermal growth factor receptor 2(HER2)-neu overexpressing adenocarcinoma
- History of previous neoadjuvant chemotherapy , radiotherapy or clinical trial treatment within 3 months
- Contraindication for anesthesia, surgery, chemotherapeutic agents or HIPEC
- Women of child-bearing potential who are pregnant or breastfeeding
- History of prior/other malignancies within the 5 years prior to enrollment
- Cerebrovascular accident occurred within 6 months (myocardial infarction, unstable angina, cerebral infarction, or cerebral hemorrhage)
- History of continuous systematic administration of corticosteroids within one month
- Requirement of simultaneous surgery for other disease
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- FEV1\<50% of predicted values
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100-142, China
Fujian Provincial Hospital
Fuzhou, Fujian, 350-014, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510-060, China
Guangdong General Hospital
Guangzhou, Guangdong, 510-080, China
Cancer Center of Guangzhou Medical University
Guangzhou, Guangdong, 510-095, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510-280, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510-515, China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510-630, China
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510-655, China
Meizhou People's Hospital
Meizhou, Guangdong, 514-031, China
Zhongshan City People Hospital
Zhongshan, Guangdong, 528-403, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200-032, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610-041, China
Related Publications (6)
Van Cutsem E, Moiseyenko VM, Tjulandin S, Majlis A, Constenla M, Boni C, Rodrigues A, Fodor M, Chao Y, Voznyi E, Risse ML, Ajani JA; V325 Study Group. Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: a report of the V325 Study Group. J Clin Oncol. 2006 Nov 1;24(31):4991-7. doi: 10.1200/JCO.2006.06.8429.
PMID: 17075117BACKGROUNDKoizumi W, Narahara H, Hara T, Takagane A, Akiya T, Takagi M, Miyashita K, Nishizaki T, Kobayashi O, Takiyama W, Toh Y, Nagaie T, Takagi S, Yamamura Y, Yanaoka K, Orita H, Takeuchi M. S-1 plus cisplatin versus S-1 alone for first-line treatment of advanced gastric cancer (SPIRITS trial): a phase III trial. Lancet Oncol. 2008 Mar;9(3):215-21. doi: 10.1016/S1470-2045(08)70035-4. Epub 2008 Feb 20.
PMID: 18282805BACKGROUNDBang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Ruschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. doi: 10.1016/S0140-6736(10)61121-X. Epub 2010 Aug 19.
PMID: 20728210BACKGROUNDFujitani K, Yang HK, Mizusawa J, Kim YW, Terashima M, Han SU, Iwasaki Y, Hyung WJ, Takagane A, Park DJ, Yoshikawa T, Hahn S, Nakamura K, Park CH, Kurokawa Y, Bang YJ, Park BJ, Sasako M, Tsujinaka T; REGATTA study investigators. Gastrectomy plus chemotherapy versus chemotherapy alone for advanced gastric cancer with a single non-curable factor (REGATTA): a phase 3, randomised controlled trial. Lancet Oncol. 2016 Mar;17(3):309-318. doi: 10.1016/S1470-2045(15)00553-7. Epub 2016 Jan 26.
PMID: 26822397BACKGROUNDHu Y, Huang C, Sun Y, Su X, Cao H, Hu J, Xue Y, Suo J, Tao K, He X, Wei H, Ying M, Hu W, Du X, Chen P, Liu H, Zheng C, Liu F, Yu J, Li Z, Zhao G, Chen X, Wang K, Li P, Xing J, Li G. Morbidity and Mortality of Laparoscopic Versus Open D2 Distal Gastrectomy for Advanced Gastric Cancer: A Randomized Controlled Trial. J Clin Oncol. 2016 Apr 20;34(12):1350-7. doi: 10.1200/JCO.2015.63.7215. Epub 2016 Feb 22.
PMID: 26903580RESULTGeng X, Liu H, Lin T, Hu Y, Chen H, Zhao L, Mou T, Qi X, Yu J, Li G. Survival benefit of gastrectomy for gastric cancer with peritoneal carcinomatosis: a propensity score-matched analysis. Cancer Med. 2016 Oct;5(10):2781-2791. doi: 10.1002/cam4.877. Epub 2016 Sep 20.
PMID: 27650694RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guoxin Li
Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group; Nanfang Hospital, Southern Medical University, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 9, 2017
First Posted
January 18, 2017
Study Start
January 1, 2016
Primary Completion
June 1, 2022
Study Completion
June 1, 2022
Last Updated
September 13, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share