UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001028 |
|---|---|
| Receipt number | 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 09:14:49 |
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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
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
kawahara@tcog.jp
Sponsor or person
Institute
The Tokyo cooperative oncology group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001240
