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Study of S1 Efficacy and Toxicity as Second-line Treatment on Inoperable or Advanced Gastric Cancers

NCT ID: NCT01650766

Last Updated: 2012-07-26

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-10-31

Brief Summary

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The primary purpose of the study is to investigate the correlation between the efficacy and toxicity of S-1 on gastric cancers and the expression of thymidylate synthase (TS), dihydropyrimidine dehydrogenase (DPD) and orotate phosphoribosyltransferase(OPRT).

Detailed Description

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TS, DPD and OPRT are the key enzymes on the metabolic pathway of 5-Fu. We will retrospectively analyze the clinicopathological features of the patients who have suffered an inoperative or recurrent gastric cancers and administrated with S-1, such as the overall survival (OS), progressive-free survival (PFS), Lauren's classification and toxicity of S1, etc. We will divide the patients into several subgroups according to the parameters above, and then investigate the correlation between the parameters and the expression of TS, DPD and OPRT.

All of the analysis is retrospective, there is no different treatment operation once the subject enrolled in this study.

Conditions

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Gastric Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Histologically confirmed, inoperable or advanced gastric cancer patients who received at most 1st line treatment
2. Aged 18 years or older
3. KPS performance status of ≥ 70.
4. Anticipated life expectancy of ≥ 3 months.
5. Adequate organ function, including bone marrow, kidney and liver.

* ANC ≥ 1.5×109/L and hemoglobin ≥ 8g/dL and platelet count ≥ 100×109/L
* Serum total bilirubin ≤ 1.5 x ULN, Serum ALT and AST ≤ 2.5 x ULN (Serum ALT and AST ≤ 5 x ULN, if liver metastases are present)
* Serum creatinine ≤ 1.5 x ULN and CLcr \> 60 ml/min
6. Written informed consent can be obtained prior to their participation in the trial.

Exclusion Criteria

1. History of severe drug allergy , or an allergy to any components of S1
2. Subjects who have received chemotherapy, immunotherapy or radiotherapy within two weeks
3. Alimentary tract hemorrhage, diarrhea or aphagosis at the present stage
4. Subjects with uncontrolled CNS metastasis or epilepsia or severe psychiatric disorders.
5. Subjects who are regarded to be unsuitable for this trial by the investigator.
6. Subjects who are participating in other clinical trials
7. Subjects with ascites draining or severe infection
8. Pregnant or breast-feeding women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Xu jianming

Director of Department of Digestive Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xu Jianming, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Locations

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307 Hospital of PLA

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Xu Jianming, M.D.

Role: primary

Other Identifiers

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AGC-307PLAH-XJM

Identifier Type: -

Identifier Source: org_study_id