UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002571 |
|---|---|
| Receipt number | R000002281 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2009/10/01 |
| Last modified on | 2009/11/13 19:53:59 |
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Basic information
Public title
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
Acronym
Trial group of Irinotecan based Chemotherapy for S-1 failed Stomach Cancer (TRICS)
Scientific Title
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
Scientific Title:Acronym
Trial group of Irinotecan based Chemotherapy for S-1 failed Stomach Cancer (TRICS)
Region
| Japan |
Condition
Condition
Gastric Cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate the superiority of combined therapy with CPT-11 and CDDP over CPT-11 monotherapy in patients with advanced or recurrent gastric cancer resistant to S-1 monotherapy using overall survival as the primary endpoint.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
overall survival
Key secondary outcomes
time to treatment failure (TTF), response rate, safety (frequency and severity of adverse events)
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 considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
CPT-11+CDDP
CPT-11 60mg/m2 d1
CDDP 30mg/m2 d1
repeat every 2weeks
until PD
Interventions/Control_2
CPT-11 alone
CPT-11 150mg/m2 d1
repeat every 2weeks
until PD
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) Histologically proven primary gastric adenocarcinoma.
(2) No previous chemotherapy (except S-1 monotherapy), immunotherapy, or radiotherapy (including local irradiation for pain control).
(3) Received S-1 monotherapy and match either of criteria <1> or <2> mentioned below. Patients who have discontinued treatment because of adverse events were excluded.
<1> Tumor progression after at least 1 cycle of S-1 monotherapy (oral administration of S-1 for 4 weeks or more) given as initial chemotherapy (patients with progressive disease: PD).
<2> Received at least 2 cycles of S-1 monotherapy (oral administration of S-1 for 8 weeks or more) as postoperative adjuvant chemotherapy and have suffered recurrence during treatment or within 6 months after the completion of treatment (patients with recurrence).
(4) Previous S-1 monotherapy completed at least 2 weeks before.
(5) Previous surgery completed at least 4 weeks before.
(6) Performance status of 0-1 (ECOG classification).
(7) Age over 20 years old.
(8) More than 12 weeks of expected survival.
(9) Adequate organ function.
* WBC >=;4,000/mm3 and=<;12,000 mm3.
* Neutrophil count >=2,000/mm3.
* Platelet count>=;100,000/mm3.
* Hemoglobin>=;8.0 g/dL
Liver function tests
* AST (GOT) and ALT (GPT)=<;100 IU/L.
* Total bilirubin=<;1.50 mg/dL.
Renal function test
* Serum creatinine=<;1.20 mg/dL.
(10) Written informed consent.
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
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshimasa Tsujinaka |
Organization
National Hospital Organization Osaka National Hospital
Division name
Surgery
Zip code
Address
Hoenzaka 2-1-1, Chuo-ku, Osaka City. Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
ECRIN
Division name
Secretariat
Zip code
Address
TEL
Homepage URL
miya@ecrin.or.jp
Sponsor or person
Institute
ECRIN
Institute
Department
Personal name
Funding Source
Organization
ECRIN
Organization
Division
Category of Funding Organization
Other
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
| 2009 | Year | 10 | 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
Open public recruiting
Date of protocol fixation
| 2007 | Year | 06 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 06 | 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
| 2009 | Year | 10 | Month | 01 | Day |
Last modified on
| 2009 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002281
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