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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002571
Receipt No. 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

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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
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization ECRIN
Division name Secretariat
Zip code
Address
TEL
Homepage URL
Email miya@ecrin.or.jp

Sponsor
Institute ECRIN
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002281

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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