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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01650766
• Other study ID #: AGC-307PLAH-XJM
• Status: Recruiting
• Phase: N/A
• First received: January 19, 2012
• Last updated: July 24, 2012
• Start date: February 2012
• Est. completion date: October 2012

Study information

• Verified date: July 2012
• Source: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Locations

Country	Name	City	State
China	307 Hospital of PLA	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Country where clinical trial is conducted

China,