Clinical trial NCT02781285: Effect Study of Clinical Outcomes of Traditional Chinese Medicine to Advanced Gastric Cancer by Propensity Score
Official title: Effect Study of Clinical Outcomes of Traditional Chinese Medicine to Advanced Gastric Cancer by Propensity Score Through Registration
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Adenocarcinoma
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Zhongshan Hospital
name: RenJi Hospital
name: Fudan University
name: ShuGuang Hospital
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Ruijin Hospital
name: Yunnan Provinical Hospital of Traditional Chinese Medicine
name: Xiyuan Hospital of China Academy of Chinese Medical Sciences
name: Shaanxi Hospital of Traditional Chinese Medicine
First posted: 2016-05-24
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Both: both female and male participants are being studied

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.

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.

Eligibility criteria: Inclusion Criteria:

* gastric adenocarcinoma without operation or recurrence after operation or metastasis
* diagnosed within three months
* KPS score≥60
* expected survival time was above 3 months
* HB ≥80g/L 、WBC≥4.0×109/L、 N ≥2.0×109/L 、PLA ≥80×109/L
* normal function with heart 、kidney and liver

Exclusion Criteria:

* not gastric adenocarcinoma
* simultaneous diagnosis with other malignant tumor
* participate in clinical trials of new drugs not listed in China
* combined with myocardial infarction, cerebral infarction, severe liver and kidney dysfunction, postoperative severe complications

Primary outcomes:
measure: 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.
timeFrame: two years
Secondary outcomes:
measure: 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.
timeFrame: two years
measure: 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.
timeFrame: two years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Longhua Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Longhua Hospital
name: zhao ai guang, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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. doi: 10.1159/000094769. Epub 2006 Jul 26.