ESCOTCMAGCPS: Effect Study of Clinical Outcomes of Traditional Chinese Medicine to Advanced Gastric Cancer by Propensity Score
Study Details
Study Description
Brief Summary
The researching subject is aimed to obtain the clinical evidences (including real benefits， risks ,etc. ) of traditional Chinese medicine in the treatment of advanced gastric cancer by compared with the outcomes that not accept the traditional Chinese medicine. the subject acquires these clinical practices by using the methods of multicenter、persisting registry (the real world researching technology ) and propensity score.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The purpose of this project is to further evaluate the role of traditional Chinese medicine in the treatment of advanced gastric cancer through clinical registration along with real world study.
The patients who suffer from advanced gastric cancer often have a very short time survival . Their total survival time is only 4.3 months after the best supportive care. At present palliative chemotherapy is still the main method for advanced gastric cancer .
In recent years, the results of international multi center phase III clinical trial show that the patients with combination chemotherapy have 8.6 months to 13.0 months survival time.
In China, the clinical curative effect of traditional Chinese medicine in the treatment of advanced gastric cancer has been part of affirmation. Some reports with large samples of clinical research show that the Traditional Chinese Medicine may prolong the survival and improve the quality of life in patients with advanced gastric cancer.
Real World Study emphasizes in epidemiological theories, clinical observational study, cross-sectional study and cohort study. The observational study of registry (registry study in clinical practice) is particularly widely used.
Clinical practice of traditional Chinese medicine in the treatment of advanced gastric cancer often relies on the accumulation of years of medical experiences and sometimes new treatment measures. There must be some objective evidences that with reasonable design, rigorous process, scientific statistics to evaluate the value of traditional Chinese medicine intervention in the comprehensive treatment of advanced gastric cancer patients in order to meet the needs of clinical practice and medical development in China.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 1group one patients with standard TCM diagnosis and treatment of gastric cancer |
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| 2 group two patients take Chinese Medicine but not with standard TCM diagnosis and treatment of gastric cancer |
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| 3group three patients take no Chinese Medicine |
Outcome Measures
Primary Outcome Measures
- The influences of traditional Chinese medicine standardized treatment on the overall survival (OS) of patients with advanced gastric cancer by the method of Propensity Score. [two years]
Two years of continuous observation after the initial diagnosis of advanced gastric cancer with 725 cases .
Secondary Outcome Measures
- The influences of traditional Chinese medicine treatment but with standardization scheme on the overall survival (OS) of patients with advanced gastric cancer by the method of Propensity Score. [two years]
Two years of continuous observation after the initial diagnosis of advanced gastric cancer with 375 cases.
- The influences of Western Medicine treatment mainly by chemotherapy on the overall survival (OS) of patients with advanced gastric cancer by the method of Propensity Score. [two years]
Two years of continuous observation after the initial diagnosis of advanced gastric cancer with 400 cases.
Eligibility Criteria
Criteria
Inclusion Criteria:
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gastric adenocarcinoma without operation or recurrence after operation or metastasis
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diagnosed within three months
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KPS score≥60
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expected survival time was above 3 months
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HB ≥80g/L 、WBC≥4.0×109/L、 N ≥2.0×109/L 、PLA ≥80×109/L
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normal function with heart 、kidney and liver
Exclusion Criteria:
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not gastric adenocarcinoma
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simultaneous diagnosis with other malignant tumor
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participate in clinical trials of new drugs not listed in China
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combined with myocardial infarction, cerebral infarction, severe liver and kidney dysfunction, postoperative severe complications
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Longhua Hospital | Shanghai | Shanghai | China | 20032 |
Sponsors and Collaborators
- Shanghai University of Traditional Chinese Medicine
- Shanghai Zhongshan Hospital
- RenJi Hospital
- Fudan University
- ShuGuang Hospital
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Ruijin Hospital
- Yunnan Provinical Hospital of Traditional Chinese Medicine
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Shaanxi Hospital of Traditional Chinese Medicine
Investigators
- Principal Investigator: zhao ai guang, Dr., Shanghai Longhua Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4. Erratum in: CA Cancer J Clin. 2011 Mar-Apr;61(2):134.
- Yilmaz U, Oztop I, Alacacioglu A, Yaren A, Tarhan O, Somali I. Irinotecan combined with infusional 5-fluorouracil and high-dose leucovorin for the treatment of advanced gastric carcinoma as the first-line chemotherapy. Chemotherapy. 2006;52(5):264-70. Epub 2006 Jul 26.
- LONGHUA-2016-SH