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

NCT01650766 | Unknown

• 1 other identifier: AGC-307PLAH-XJM
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Gastric Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with inoperable or advanced gastric cancers

You may qualify if:

• Histologically confirmed, inoperable or advanced gastric cancer patients who received at most 1st line treatment
• Aged 18 years or older
• KPS performance status of ≥ 70.
• Anticipated life expectancy of ≥ 3 months.
• 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
• Written informed consent can be obtained prior to their participation in the trial.

You may not qualify if:

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

Sponsors & Collaborators

• The Affiliated Hospital of the Chinese Academy of Military Medical Sciences: lead

Study Sites (1)

307 Hospital of PLA

Beijing, Beijing Municipality, 100071, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Xu Jianming, M.D.

  The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Digestive Oncology

Study Record Dates

• First Submitted: January 19, 2012
• First Posted: July 26, 2012
• Study Start: February 1, 2012
• Study Completion: October 1, 2012
• Last Updated: July 26, 2012

Record last verified: 2012-07

Locations

CN (1)