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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001028
Receipt No. R000001240
Scientific Title Randomized Phase III Trial of Irinotecan plus Cisplatin vs. bi-weekly Irinotecan after S-1 failure for Patients with Advanced and Recurrent Gastric Cancer
Date of disclosure of the study information 2008/04/01
Last modified on 2014/02/13

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Basic information
Public title Randomized Phase III Trial of Irinotecan plus Cisplatin vs. bi-weekly Irinotecan after S-1 failure for Patients with Advanced and Recurrent Gastric Cancer
Acronym Randomized Phase III Trial of Irinotecan plus Cisplatin vs. bi-weekly Irinotecan after S-1 failure for Patients with Advanced and Recurrent Gastric Cancer
(TCOG GI-0801)
Scientific Title Randomized Phase III Trial of Irinotecan plus Cisplatin vs. bi-weekly Irinotecan after S-1 failure for Patients with Advanced and Recurrent Gastric Cancer
Scientific Title:Acronym Randomized Phase III Trial of Irinotecan plus Cisplatin vs. bi-weekly Irinotecan after S-1 failure for Patients with Advanced and Recurrent Gastric Cancer
(TCOG GI-0801)
Region
Japan

Condition
Condition S-1 failure for Patients with Advanced and Recurrent Gastric Cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 It makes comparative study of Time to Progression of Irinotecan plus Cisplatin vs. bi-weekly Irinotecan after S-1 failure for Patients with Advanced and Recurrent Gastric Cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Progression-free Survival
Key secondary outcomes OS
TTF
Anti-tumor Effect(Response rate)
Adverse Event

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 CPT-11+CDDP arm:
CPT-11(60mg/m2) day1
CDDP(30mg/m2) day1
Every 2 weeks
Interventions/Control_2 CPT-11 arm:
CPT-11(150mg/m2) day1
Every 2 weeks
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. With at least one measurable lesion (RECIST)
3. S-1 failure for Patients with Advanced and Recurrent Gastric Cancer
4. No prior immunotherapy and radiotherapy
5. 2 weeks or more pass from first line chemotherapy ends.
6. 4 weeks or more pass from Operation(Only the case who operated)
7. ECOG performance status<=2
8. Age 20 years old or more
9. Life expectancy estimated>=12 weeks
10. Sufficient organ functions
11.With written IC

Key exclusion criteria 1. a patient who received transfusion,
blood products, or hematopoietic growth factors such as G-CSF within 7 days prior to the registration
2. S-1+CPT-11 combination therapy as the first line chemotherapy
3. Advanced gastric cancer that refuses operation
4. History of severe drug allergic reaction
5.serious pleural effusion or ascites
6.serious Infectious disease
7. Watery diarrhea
8. Intestinal obstruction or Intestines paralysis
9. Intestinal fresh hemorrhage
10. With serious lung disease
11.administering atazanavir sulfate
12. Symptomatic brain metastasis
13. Active secondary cancer
14. cardiac disease
15. psychiatric disease or nervous disease
16. preganat or nursing patients and patients who may be pregnant
17. Decision as ineligible by principal investigator


Target sample size 130

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Wasaburou Koizumi
Organization Kitazato Univercity East Hospital
Division name Digestive Internal Medicine
Zip code
Address 2-1-1 Asamizodai Sagamihara-shi Kanagawa Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization The Tokyo cooperative oncology group
Division name Clinical Study Promotion Agency
Zip code
Address
TEL
Homepage URL
Email kawahara@tcog.jp

Sponsor
Institute The Tokyo cooperative oncology group
Institute
Department

Funding Source
Organization The Tokyo cooperative oncology group
Organization
Division
Category of Funding Organization Self funding
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
2008 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
2008 Year 02 Month 15 Day
Date of IRB
Anticipated trial start date
2008 Year 03 Month 01 Day
Last follow-up date
2012 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 02 Month 13 Day
Last modified on
2014 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001240

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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