UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025367
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public 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
Acronym Meta-analysis of TCOG GI-0801BIRIP and ECRIN TRICS RCTs as second-line treatment for advanced gastric cancer
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
Scientific Title:Acronym Meta-analysis of TCOG GI-0801BIRIP and ECRIN TRICS RCTs as second-line treatment for advanced gastric cancer
Region
Japan

Condition
Condition Advanced gastric cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Overall survival: OS
Key secondary outcomes PFS: Progression-free survival
TTF: time to treatment failure
RR: Response rate
DCR: Disease control rate
Adverse events

Base
Study type Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 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
Key exclusion 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.
Target sample size 298

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Wasaburo Koizum
Organization Kitasato University
Division name Department of Gastroenterology
Zip code
Address 1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, 252-0374, Japan
TEL 042-778-8111
Email koizumi@med.kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Nishikawa
Organization Osaka National Hospital
Division name Department of Surgery
Zip code
Address 2-1-14, Houenzaka, Chuo-ku, Osaka, 540-0006
TEL 06-6942-1331
Homepage URL
Email kazuno13@hotmail.co.jp

Sponsor
Institute Epidemiological and Clinical research Information Network (ECRIN)
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 05 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 12 Month 22 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 02 Month 17 Day

Other
Other related information 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.

Management information
Registered date
2016 Year 12 Month 22 Day
Last modified on
2018 Year 12 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029146

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.