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

This study is currently recruiting participants.
Verified July 2012 by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Xu jianming, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
ClinicalTrials.gov Identifier:
NCT01650766
First received: January 19, 2012
Last updated: July 24, 2012
Last verified: July 2012
  Purpose

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).


Condition
Gastric Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study of S1 Efficacy and Toxicity as Second-line Treatment on Inoperable or Advanced Gastric Cancers

Resource links provided by NLM:


Further study details as provided by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences:

Biospecimen Retention:   Samples With DNA

The paraffin-embedded pathelogical tissues of tumors and the blood samples before and after medication are retained.


Estimated Enrollment: 80
Study Start Date: February 2012
Estimated Study Completion Date: October 2012
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients with inoperable or advanced gastric cancers

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650766

Locations
China, Beijing
307 Hospital of PLA Recruiting
Beijing, Beijing, China, 100071
Contact: Xu Jianming, M.D.    +861051168358    jmxu2003@yahoo.com   
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Xu jianming, Director of Department of Digestive Oncology, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
ClinicalTrials.gov Identifier: NCT01650766     History of Changes
Other Study ID Numbers: AGC-307PLAH-XJM
Study First Received: January 19, 2012
Last Updated: July 24, 2012
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on April 17, 2014