Unique ID issued by UMIN | UMIN000025367 |
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Receipt number | R000029146 |
Scientific Title | IPD meta-analysis of biweekly irinotecan plus cisplatin and irinotecan alone as second-line treatment for advanced gastric cancer: TCOG GI-0801BIRIP and ECRIN TRICS RCTs |
Date of disclosure of the study information | 2017/01/05 |
Last modified on | 2018/12/26 09:48:32 |
IPD meta-analysis of biweekly irinotecan plus cisplatin and irinotecan alone as second-line treatment for advanced gastric cancer: TCOG GI-0801BIRIP and ECRIN TRICS RCTs
Meta-analysis of TCOG GI-0801BIRIP and ECRIN TRICS RCTs as second-line treatment for advanced gastric cancer
IPD meta-analysis of biweekly irinotecan plus cisplatin and irinotecan alone as second-line treatment for advanced gastric cancer: TCOG GI-0801BIRIP and ECRIN TRICS RCTs
Meta-analysis of TCOG GI-0801BIRIP and ECRIN TRICS RCTs as second-line treatment for advanced gastric cancer
Japan |
Advanced gastric cancer
Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Malignancy
NO
The purpose of the study is to evaluate the efficacy and safety of biweekly CPT-11 plus CDDP comparing to CPT-11 monotherapy in patients with advanced gastric cancer who had received S-1 based first line chemotherapy.
1. Comparison of effectiveness between biweekly irinotecan plus cisplatin vs. irinotecan alone
2. To identify subgroups, biomarkers, most likely benefit from each treatment: previous treatment with cisplatin, histological cancer types etc.
3. Comparison of effectiveness between patients who relapsed during or within 6 months after adjuvant chemotherapy and patients after first line chemotherapy.
Safety,Efficacy
Exploratory
Explanatory
Not applicable
Overall survival: OS
PFS: Progression-free survival
TTF: time to treatment failure
RR: Response rate
DCR: Disease control rate
Adverse events
Others,meta-analysis etc
20 | years-old | <= |
Not applicable |
Male and Female
1.With pathologically proven gastric cancer
2. S-1 failure for Patients with Advanced and Recurrent Gastric Cancer
3. ECOG performance status<=2
4. Age 20 years old or more
5. Life expectancy estimated>=12 weeks
6. Sufficient organ functions
(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.
298
1st name | |
Middle name | |
Last name | Wasaburo Koizum |
Kitasato University
Department of Gastroenterology
1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, 252-0374, Japan
042-778-8111
koizumi@med.kitasato-u.ac.jp
1st name | |
Middle name | |
Last name | Kazuhiro Nishikawa |
Osaka National Hospital
Department of Surgery
2-1-14, Houenzaka, Chuo-ku, Osaka, 540-0006
06-6942-1331
kazuno13@hotmail.co.jp
Epidemiological and Clinical research Information Network (ECRIN)
None
Non profit foundation
NO
2017 | Year | 01 | Month | 05 | Day |
Published
Cumulative data from eligible 290 patients from these two trials were evaluated. OS were 12.3 in BIRIP group and 11.3 months in CPT-11 group (HR 0.87; P = 0.272). PFS was significantly longer in BIRIP group (4.3months) than in CPT-11 group (3.3months; HR 0.77, P = 0.035). The response rate was 20.5% in BIRIP group and 16.0% in CPT-11 group (P = 0.361). However, the disease control rate was significantly better in BIRIP group (72.1%) than in CPT-11 group (59.2%) (P = 0.032). The incidences of grade 3 or worse adverse events did not differ between the two groups.
Completed
2016 | Year | 12 | Month | 22 | Day |
2017 | Year | 01 | Month | 10 | Day |
2018 | Year | 02 | Month | 17 | Day |
Two randomized trials of biweekly CPT-11 plus CDDP versus CPT-11 alone in second line, TCOG GI-0801BIRIP trial and ECRIN TRICS trial were done without overall survival benefit; although there were trends for better survival for CPT-11 plus CDDP.
Based on these findings, we conducted meta-analysis to compare the efficacy and safety of biweekly CPT-11 plus CDDP and CPT-11 monotherapy in 300 patients who enrolled these two recent randomized trials. Also we identify subgroups who would benefit from each treatment.
2016 | Year | 12 | Month | 22 | Day |
2018 | Year | 12 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029146
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