To Observe the Efficacy and Safety by Comparing Chemotherapy(Docetaxel, Oxaliplatin Plus S1 ) Followed With Radical Resection Versus Chemotherapy Alone in Advanced Gastric Cancer With Single Non-curable Factor.
NCT ID: NCT03001726
Last Updated: 2022-05-06
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
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UNKNOWN
228 participants
OBSERVATIONAL
2017-01-31
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Gastrectomy plus chemotherapy
In patients assigned to surgery followed by chemo- therapy, a total, distal, or proximal gastrectomy with metastasis dissection was done depending on tumour location.
Gastrectomy
In patients assigned to surgery followed by chemo- therapy, a total, distal, or proximal gastrectomy with metastasis dissection was done depending on tumour location.
oxaliplatin
oxaliplatin 100 mg/m2
S1
S1 40mg/m2
Docetaxel
docetaxel 40 mg/m2
chemotherapy alone
Patients received chemotherapy alone.All patients received oral S1 80 mg/m2 per day (80-120 mg/day total dose depending on the patient's body surface area as follows: \<1.25 m2, 80 mg; 1.25-1.5 m2, 100 mg; and \>1.5 m2, 120 mg) on days 1-21 of every 3-week cycle, oxaliplatin 100 mg/m2 on day 1 of every 3-week cycle and docetaxel 40mg/m2 on day 1 of every 3-weeks cycle.
oxaliplatin
oxaliplatin 100 mg/m2
S1
S1 40mg/m2
Docetaxel
docetaxel 40 mg/m2
Interventions
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Gastrectomy
In patients assigned to surgery followed by chemo- therapy, a total, distal, or proximal gastrectomy with metastasis dissection was done depending on tumour location.
oxaliplatin
oxaliplatin 100 mg/m2
S1
S1 40mg/m2
Docetaxel
docetaxel 40 mg/m2
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A single non-curable factor was defined as hepatic metastasis (H1; two to four lesions of maximum diameter ≤5 cm and minimum diameter ≥1 cm); peritoneal metastasis (P1) in the diaphragm or peritoneum caudal to the transverse colon without massive ascites or intestinal obstruction; positive cytology (CY1) when the cancer cells were found in the peritoneal washing; para-aortic lymph node (PAN) metastasis above the coeliac axis or below the inferior mesenteric artery (lymph node 16a1/b2 of maximum diameter ≥1 cm), or both; or ovary implant metastasis for one site or two.
Exclusion Criteria
* Patietns who have more than one metastasis.
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Tianshu Liu
Chairman for the department of oncology
Principal Investigators
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Tianshu Liu, Physician
Role: PRINCIPAL_INVESTIGATOR
Zhongshan Hopital
Locations
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Zhongshan hospital
Shanghai, Shanghai Municipality, China
Countries
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References
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Cui Y, Yu Y, Zheng S, Ying J, Du Y, Wang Y, Wang X, Shen Z, Liu F, Lv M, Sun Y, Liu T. Does resection after neoadjuvant chemotherapy of docetaxel, oxaliplatin, and S-1 (DOS regimen) benefit for gastric cancer patients with single non-curable factor? a multicenter, prospective cohort study (Neo-REGATTA). BMC Cancer. 2023 Apr 4;23(1):308. doi: 10.1186/s12885-023-10773-x.
Other Identifiers
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NEO-REGATTA
Identifier Type: -
Identifier Source: org_study_id
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