Stomach NeoplasmPhase 3NCT03023436
Cytoreductive Surgery Combined With HIPEC and Chemotherapy for Gastric Cancer With Peritoneal Metastasis
A Phase 3 study testing Cytoreductive surgery, Hyperthermic Intraperitoneal Chemotherapy and Fluoropyrimidine in people with Stomach Neoplasm, run by Nanfang Hospital, Southern Medical University at 13 sites in China.
Trial summary
This study evaluates the survival benefit and safety of cytoreductive surgery(CRS) combined with HIPEC and chemotherapy in gastric cancer with peritoneal metastasis. Read more about this study
- Who is it for?
- Ages 19 to 74 years
- Conditions the study is for
- Stomach Neoplasm
- What is being tested?
- Cytoreductive surgery, Hyperthermic Intraperitoneal Chemotherapy and Fluoropyrimidine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 13 sitesChina
- Study dates
- Jan 2016to Jun 2022
- Phase
- Phase 3
- 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 19 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites, 13 recruiting
- Recruiting
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100-142
Xiangqian Su, M.D., Ph.D., +86-138-0126-2916
Xiangqian Su, M.D., Ph.D
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610-041
Jiankun Hu, M.D., Ph.D., +86-189-8060-1504, hujkwch@126.com
Jiankun Hu, M.D.,Ph.D.
- Recruiting
Fujian Provincial Hospital
Fuzhou, Fujian, 350-014
Liangxiang Huang, M.D., Ph.D., 0086-138-5902-0211
Liangxiang Huang, M.D., Ph.D.
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510-060
Zhiwei Zhou, M.D., Ph.D., +86-139-0222-2859, zhouzhw@sysucc.org.cn
Zhiwei Zhou, M.D., Ph.D.
- Recruiting
Guangdong General Hospital
Guangzhou, Guangdong, 510-080
Yong Li, M.D., Ph.D., +86-138-2217-7479, yuan821007@126.com
Yong Li, M.D., Ph.D.
- Recruiting
Cancer Center of Guangzhou Medical University
Guangzhou, Guangdong, 510-095
Shuzhong Cui, M.D., Ph.D., +86-138-0251-3800, cuishuzhong@126.com
cuishuzhong@126.com Cui, M.D., Ph.D.
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510-280
Jinlong Yu, M.D., Ph.D., +86-131-8909-7861, yujinlong640506@163.com
Jinlong Yu, M.D., Ph.D.
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510-515
Guoxin Li, M.D., Ph.D., +86-138-0277-1450, gzliguoxin@163.com
Hao Liu, M.D., Ph.D., +86-138-2215-8578, liuhaofbi@163.com
- Recruiting
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510-630
Hong-Bo Wei, M.D., Ph.D., 0086-18922102969, drweihb@126.com
Bo Wei, M.D., 0086-13527794069, sanpi2013@163.com
- Recruiting
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510-655
Junsheng Peng, M.D., Ph.D., +86-138-0296-3578, pengsir1010@126.com
Junsheng Peng, M.D., Ph.D.
- Recruiting
Meizhou People's Hospital
Meizhou, Guangdong, 514-031
Zuguang Wu, M.D., +86-135-0252-3063, wuzg1913@163.com
Zuguang Wu, M.D.
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200-032
Yihong Sun, M.D., Ph.D., +86-137-0173-5406, yihongsun@medmail.com.cn
Yihong Sun, M.D., Ph.D.
- Recruiting
Zhongshan City People Hospital
Zhongshan, Guangdong, 528-403
Hong Chen, M.D., Ph.D., +86-135-9084-3781, cenhong228@sohu.com
Hong Chen, M.D., Ph.D.
About this study
Official title: Cytoreductive Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy and Systemic Chemotherapy in Gastric Cancer With Regional Peritoneal Metastasis, a Multicenter and Single-arm Phase III Study
This study evaluates the survival benefit and safety of cytoreductive surgery(CRS) combined with HIPEC and chemotherapy in gastric cancer with peritoneal metastasis.
Read the detailed description
Peritoneal metastasis is one of the most frequent non-curable factors in advanced gastric cancer with poor prognosis, the median survival time of patients is less than 1 year and even worse in China. Recently, several new modalities have been developed and reported to improve survival, including the new chemotherapeutic agents, molecular targeting agents and hyperthermic intraperitoneal chemotherapy（HIPEC）.Still, the long-term outcomes based on multicenter randomized clinical trials (RCTs) are awaited.
The surgical approach to metastatic lesions has been proved to play a very crucial role in prolonging the survival of metastatic colorectal patients, which might be able to cure patients with the operation aiming at R0 resection. For patients with metastatic gastric cancer, surgical intervention of primary tumor and measurable metastatic lesion is technically feasible, while the survival benefit is controversial. Even though the REGATTA trial demonstrated that the removal of the primary tumor is not necessarily beneficial, the role of operation aiming at R0 resection combined with new regimens like HIPEC and new chemotherapeutic agents is still confusing and new categories of classification for metastatic gastric cancer based on the treatment response is needed.
In order to evaluate the survival benefit and safety of cytoreductive surgery(CRS) and HIPEC before beginning chemotherapy in gastric cancer with peritoneal metastasis, patients who fulfill the inclusion and exclusion criteria will be recruited in this study and receive CRS, HIPEC and chemotherapy. Chemotherapy regimen based on cisplatin and fluorouracil(CF) are recommended. Patients are followed up for 2 years and the safety and survival outcome will be analyzed.
- Conditions
- Stomach Neoplasm
- Being tested
- Cytoreductive surgery, Hyperthermic Intraperitoneal Chemotherapy, Fluoropyrimidine, Cisplatin
- Keywords
- Stomach Neoplasms, Cytoreduction Surgical Procedures
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytoreductive surgeryProcedure or surgery
Also called CRS , Cytoreduction Surgical Procedures
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.
Hyperthermic Intraperitoneal ChemotherapyProcedure or surgery
Also called HIPEC
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.
FluoropyrimidineDrug
Also called fluorouracil or capecitabine
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.
CisplatinDrug
Also called cis-diamine dichloroplatinum(CDDP)
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.
| Study group | Role | What they receive |
|---|---|---|
| CRS + HIPEC + Systemic Chemotherapy | Experimental | Cytoreductive 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. Receives: Procedure: Cytoreductive surgery; Procedure: Hyperthermic Intraperitoneal Chemotherapy; Drug: Fluoropyrimidine; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year Median survival time
The time point when the cumulative survival rate is 50% according to the survival curve.
Measured: 24 months
Secondary outcomes (3)
2-year overall survival rate
Overall survival rate calculated according to the survival curve.
Measured: 24 months
Progression free survival rate
Progression free survival rate calculated according to the disease progression curve.
Measured: 24 months
Morbidity and mortality
The early complication and mortality are defined as the event observed within 30 days after intervention, while the time frame for late complication is the period beyond 30 days after intervention to the end of month 24th. Complications are ranked from grade 0-5 according to CTCAE V4.0
Measured: 30 days; 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startJan 2016
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Stomach NeoplasmStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guoxin Li, Nanfang Hospital, Southern Medical University
- Investigators
- Guoxin Li, Principal investigator, Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group; Nanfang Hospital, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023436
- Sponsor's protocol ID
- CLASS - 05
- Status last verified
- Sep 2019
- First submitted
- 9 Jan 2017
- Last updated
- 13 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 17075117Koizumi 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.
PubMed 18282805Bang 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.
PubMed 20728210Fujitani 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.
PubMed 26822397Hu 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.
PubMed 26903580Geng 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.
PubMed 27650694
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytoreductive Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy and Systemic Chemotherapy in Gastric Cancer With Regional Peritoneal Metastasis, a Multicenter and Single-arm Phase III Study
- ClinicalTrials.gov ID
- NCT03023436
- Acronym / sponsor ID
- CLASS - 05
- Conditions
- Stomach Neoplasm
- Keywords
- Stomach Neoplasms, Cytoreduction Surgical Procedures
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 18 Jan 2017 (estimated)
- 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.
This study evaluates the survival benefit and safety of cytoreductive surgery(CRS) combined with HIPEC and chemotherapy in gastric cancer with peritoneal metastasis.
Detailed description
Peritoneal metastasis is one of the most frequent non-curable factors in advanced gastric cancer with poor prognosis, the median survival time of patients is less than 1 year and even worse in China. Recently, several new modalities have been developed and reported to improve survival, including the new chemotherapeutic agents, molecular targeting agents and hyperthermic intraperitoneal chemotherapy（HIPEC）.Still, the long-term outcomes based on multicenter randomized clinical trials (RCTs) are awaited.
The surgical approach to metastatic lesions has been proved to play a very crucial role in prolonging the survival of metastatic colorectal patients, which might be able to cure patients with the operation aiming at R0 resection. For patients with metastatic gastric cancer, surgical intervention of primary tumor and measurable metastatic lesion is technically feasible, while the survival benefit is controversial. Even though the REGATTA trial demonstrated that the removal of the primary tumor is not necessarily beneficial, the role of operation aiming at R0 resection combined with new regimens like HIPEC and new chemotherapeutic agents is still confusing and new categories of classification for metastatic gastric cancer based on the treatment response is needed.
In order to evaluate the survival benefit and safety of cytoreductive surgery(CRS) and HIPEC before beginning chemotherapy in gastric cancer with peritoneal metastasis, patients who fulfill the inclusion and exclusion criteria will be recruited in this study and receive CRS, HIPEC and chemotherapy. Chemotherapy regimen based on cisplatin and fluorouracil(CF) are recommended. Patients are followed up for 2 years and the safety and survival outcome will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRS + HIPEC + Systemic Chemotherapy | Experimental | Procedure: Cytoreductive surgery, Procedure: Hyperthermic Intraperitoneal Chemotherapy, Drug: Fluoropyrimidine, Drug: CisplatinCytoreductive 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. |
Who may qualify
- Ages
- 19 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 )
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| Cytoreductive surgeryAlso: CRS , Cytoreduction Surgical ProceduresGastrectomy 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. | Procedure or surgery | CRS + HIPEC + Systemic Chemotherapy |
| Hyperthermic Intraperitoneal ChemotherapyAlso: HIPECDocetaxel 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. | Procedure or surgery | CRS + HIPEC + Systemic Chemotherapy |
| FluoropyrimidineAlso: fluorouracil or capecitabineCF 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. | Drug | CRS + HIPEC + Systemic Chemotherapy |
| CisplatinAlso: cis-diamine dichloroplatinum(CDDP)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. | Drug | CRS + HIPEC + Systemic Chemotherapy |
Primary outcome
2-year Median survival time
Time frame: 24 months
The time point when the cumulative survival rate is 50% according to the survival curve.
3 secondary outcomes
2-year overall survival rate
Time frame: 24 months
Progression free survival rate
Time frame: 24 months
Morbidity and mortality
Time frame: 30 days; 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
- Background: PubMed 17075117Van 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.
- Background: PubMed 18282805Koizumi 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.
- Background: PubMed 20728210Bang 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.
- Background: PubMed 26822397Fujitani 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.
- Results publication: PubMed 26903580Hu 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.
- Results publication: PubMed 27650694Geng 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.
- Individual participant dataSharing planned: No
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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.
Guoxin Li principal investigator
Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group; Nanfang Hospital, Southern Medical University, China
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cytoreductive surgery, Hyperthermic Intraperitoneal Chemotherapy and Fluoropyrimidine in people with Stomach Neoplasm, run by Nanfang Hospital, Southern Medical University at 13 sites 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 7 inclusion and 12 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 13 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Guoxin Li, M.D., Ph.D. (+86-138-0277-1450, gzliguoxin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year Median survival time (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03023436, which also lists 6 linked publications.
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 13 Sep 2019.