The Effect of Traditional Chinese Treatment Combined Adjuvant Chemotherapy in IIIb and IIIc Gastric Cancer
NCT ID: NCT03607656
Last Updated: 2023-12-18
Study Results
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Basic Information
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COMPLETED
PHASE2/PHASE3
270 participants
INTERVENTIONAL
2018-06-08
2023-11-30
Brief Summary
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Detailed Description
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Metastasis and recurrence is the primary cause in decreasing the survival time of gastric cancer patients who experienced radical operation. Among whom, patients with stage IIIB and IIIC are especially in high risk of metastasis and recurrence, result in a significant poor survival time than patients with earlier stages.
Oxaliplatin with capecitabine is the standard adjuvant chemotherapy for curative D2 gastrostomy gastric cancer, contribute the 3-year disease free survival rate of 74% in ITT, and 61% in stage IIIB sub-group. Meanwhile, Traditional Chinese Medicine (TCM) treatment has been used for thousands of years in Chinese clinical practices. In China, the clinical curative effect of TCM in the treatment of gastric cancer has been part of affirmation. Some reports with large samples of clinical research show that the TCM is effective and safety for gastric cancer.In order to evaluate efficacy on TCM combined adjuvant chemotherapy in IIIB and IIIC gastric cancer, we design this randomized, open-label study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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TCM combines CapOX/SOX/S-1+D/FLOT
Traditional Chinese Medicine oral taken twice a day for at least 3 months combined with chemotherapy.
The chemotherapy can choose intravenous oxaliplatin 130 mg/m(2) on day 1 plus oral capecitabine 1000 mg/m(2) twice daily on days 1-14, every 21 days; or intravenous oxaliplatin 100 mg/m(2) on day 1 plus oral S-1 40mg/m(2) twice daily on days 1-14, every 21 days; or intravenous docetaxel 40mg/m(2) on day 1 plus oral S-1 40mg/m(2) twice daily on days 1-14, every 21 days; or intravenous docetaxel 50mg/m(2) on day 1 plus intravenous oxaliplatin 85 mg/m(2) on day 1 plus 5-FU intravenously CIV24h on day 1, every 14 days; Each participant shoud take eight (8) cycles of chemotherapy.
Oxaliplatin
Oxaliplatin powder injection
Capecitabine
Capecitabine tablet
TCM
TCM decoction orally taken twice a day for at least 3 months
S-1
S-1 capsule
Docetaxel
Docetaxel injection
5-FU
5-FU injection
CapOX/SOX/S-1+D/FLOT
The chemotherapy can choose intravenous oxaliplatin 130 mg/m(2) on day 1 plus oral capecitabine 1000 mg/m(2) twice daily on days 1-14, every 21 days; or intravenous oxaliplatin 100 mg/m(2) on day 1 plus oral S-1 40mg/m(2) twice daily on days 1-14, every 21 days; or intravenous docetaxel 40mg/m(2) on day 1 plus oral S-1 40mg/m(2) twice daily on days 1-14, every 21 days; or intravenous docetaxel 50mg/m(2) on day 1 plus intravenous oxaliplatin 85 mg/m(2) on day 1 plus 5-FU intravenously CIV24h on day 1, every 14 days; Each participant shoud take eight (8) cycles of chemotherapy.
Oxaliplatin
Oxaliplatin powder injection
Capecitabine
Capecitabine tablet
S-1
S-1 capsule
Docetaxel
Docetaxel injection
5-FU
5-FU injection
Interventions
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Oxaliplatin
Oxaliplatin powder injection
Capecitabine
Capecitabine tablet
TCM
TCM decoction orally taken twice a day for at least 3 months
S-1
S-1 capsule
Docetaxel
Docetaxel injection
5-FU
5-FU injection
Eligibility Criteria
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Inclusion Criteria
* Karnofsky performance status higher than 70;
* Adequate hepatic, renal, cardio and hematologic function;
* With patients' consent and comply to long term follow-up.
Exclusion Criteria
* Histological type beyond gastric carcinoma;
* Conversion chemotherapy before surgery;
* Concurrent cancer;
* Women of gravid or lactating; patients with mental illness;
* Uncontrolled significant comorbid conditions.
18 Years
80 Years
ALL
No
Sponsors
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RenJi Hospital
OTHER
Jiangsu Province Hospital of Traditional Chinese Medicine
OTHER
Shanghai University of Traditional Chinese Medicine
OTHER
Responsible Party
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zhaoaiguang
Principal Investigator, Clinical Professor
Principal Investigators
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Aiguang Zhao, M.D.,Ph.D
Role: PRINCIPAL_INVESTIGATOR
Shanghai University of Traditional Chinese Medicine
Locations
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Longhua Hospital
Shanghai, Shanghai Municipality, China
Countries
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References
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Bang YJ, Kim YW, Yang HK, Chung HC, Park YK, Lee KH, Lee KW, Kim YH, Noh SI, Cho JY, Mok YJ, Kim YH, Ji J, Yeh TS, Button P, Sirzen F, Noh SH; CLASSIC trial investigators. Adjuvant capecitabine and oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): a phase 3 open-label, randomised controlled trial. Lancet. 2012 Jan 28;379(9813):315-21. doi: 10.1016/S0140-6736(11)61873-4. Epub 2012 Jan 7.
Xu Y, Zhao AG, Li ZY, Zhao G, Cai Y, Zhu XH, Cao ND, Yang JK, Zheng J, Gu Y, Han YY, Zhu YJ, Yang JZ, Gao F, Wang Q. Survival benefit of traditional Chinese herbal medicine (a herbal formula for invigorating spleen) for patients with advanced gastric cancer. Integr Cancer Ther. 2013 Sep;12(5):414-22. doi: 10.1177/1534735412450512. Epub 2012 Jul 9.
Li Z, Zhang G, Cao N, Xu J, Dong J, Li J, Zhu X, Xu Y, Han C, Wang R, Xia X, Zhao G, Huan X, Fan J, Zhao A. Effects of traditional Chinese medicine collaborative model (TCMCM) combined with adjuvant chemotherapy on IIIb and IIIc gastric cancer: a protocol for a randomized controlled trial. Trials. 2022 Jan 21;23(1):68. doi: 10.1186/s13063-022-06013-5.
Other Identifiers
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LONGHUA-2018-SH
Identifier Type: -
Identifier Source: org_study_id