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

July 24, 2012 updated by: Xu jianming, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
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).

Study Overview

Status

Unknown

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100071
        • Recruiting
        • 307 Hospital of PLA
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with inoperable or advanced gastric cancers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Investigators

  • Principal Investigator: Xu Jianming, M.D., The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Study Completion (Anticipated)

October 1, 2012

Study Registration Dates

First Submitted

January 19, 2012

First Submitted That Met QC Criteria

July 24, 2012

First Posted (Estimate)

July 26, 2012

Study Record Updates

Last Update Posted (Estimate)

July 26, 2012

Last Update Submitted That Met QC Criteria

July 24, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGC-307PLAH-XJM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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