A Randomised phase III clinical trial of combined therapy with CPT-11/CDDP versus CPT-11 alone in patients with advaneced or recurrent gastric cancer resistant to S-1

UMIN ID: UMIN000002571

Registered date:01/10/2009

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Gastric Cancer
• Date of first enrollment: 2007/07/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

CPT-11+CDDP CPT-11 60mg/m2 d1 CDDP 30mg/m2 d1 repeat every 2weeks until PD
CPT-11 alone CPT-11 150mg/m2 d1 repeat every 2weeks until PD

Outcome(s)

• Primary Outcome: overall survival
• Secondary Outcome: time to treatment failure (TTF), response rate, safety (frequency and severity of adverse events)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: (1) Blood transfusion, blood products, or hematopoietic factor products, such as G-CSF, within 14 days before enrollment of this study. (2) Present and/or drug hypersensitivity or severe drug allergy. (3) Active double cancer. (4) With uncontrolled pleural effusion or ascites. (5) With pericardial effusion. (6) With infectious disease which needs treatment. (7) With symptomatic brain metastasis. (8) With marked ECG abnormalities. (9) With serve heart diseases, such as congestive heart failure, symptomatic coronary artery disease, inadequately controlled arrhythmia, myocardial infarction during the previous 12 months, etc. (10) With severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema, etc.). (11) With fresh gastrointestinal hemorrhage. (12) Watery stool (diarrhea). (13) Intestinal paralysis or ileus. (14) With a history of central nervous system disorder. (15) With senile dementia. (16) With psycologic disorder which disturbs recruiting to the study (17) Uncontrolled diabetes mellitus. (18) Receiving atazanavir sulfate. (19) Pregnant and/or nursing women. (20) Inappropriate recruit to the study judged by an investigator in charge.

Related Information

• Primary Sponsor: ECRIN
• Source(s) of Monetary Support: ECRIN