UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000770 |
|---|---|
| Receipt number | R000000899 |
| Scientific Title | Randomized pilot study comparing safety of irinotecan+S-1(IRIS)+bevacizumab and mFOLFIRI+bevacizumab for metastatic colorectal cancer (T-CORE0702) |
| Date of disclosure of the study information | 2007/07/22 |
| Last modified on | 2014/02/21 14:44:58 |
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Basic information
Public title
Randomized pilot study comparing safety of irinotecan+S-1(IRIS)+bevacizumab and mFOLFIRI+bevacizumab for metastatic colorectal cancer (T-CORE0702)
Acronym
Randomized pilot study comparing safety of irinotecan+S-1(IRIS)+bevacizumab and mFOLFIRI+bevacizumab for metastatic colorectal cancer (T-CORE0702)
Scientific Title
Randomized pilot study comparing safety of irinotecan+S-1(IRIS)+bevacizumab and mFOLFIRI+bevacizumab for metastatic colorectal cancer (T-CORE0702)
Scientific Title:Acronym
Randomized pilot study comparing safety of irinotecan+S-1(IRIS)+bevacizumab and mFOLFIRI+bevacizumab for metastatic colorectal cancer (T-CORE0702)
Region
| Japan |
Condition
Condition
1st line or 2nd line therapy for unresectable colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We confirm safety and efficacy of modified FOLFIRI and IRIS as a 1st-line or a 2nd-line chemotherapy in patients with unresectable advanced and recurrenct colorectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
safety
Key secondary outcomes
response rate and progression free survival (PFS)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
FOLFIRI + bevacizumab consisted of bevacizumab 5mg/kg as a 90-minute infusion, then, l-LV 200 mg/m2 as a 2-hour infusion, and irinotecan 150 mg/m2 given as a 90-minute infusion, followed by bolus FU 400 mg/m2 and a 46-hour infusion FU 2,400 mg/m2, repeated every 2 weeks.
Interventions/Control_2
IRIS + bevacizumab consisted of bevacizumab 7.5mg/kg as a 90-minute infusion, then, irinotecan 150 mg/m2 given as a 90-minute infusion, followed by oral S-1 (40 mg/m2) twice daily 14 days (day 3 to 16) followed by 5 days rest, repeated every 3 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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The criteria for eligibility were histologically proven
colorectal cancer of ; an age of 20 to 75 years; with an unresectable primary tumor or with one or more unresectable metatatic tumor(s); no previous treatment for primary cancer except for the initial colorectal resection for the primary lesion, or no previous treatment for recurrent cancer (recurrent within 6 months from the end of adjuvant chemotherapy after primary surgery, should be excluded) or one privious treatment by FOLFOX regimen ; with performance status (ECOG) 0 or 1; and adequate organ function (a leukocyte count of 3500 or more and 12,000 or less per cubic millimeter ; a platelet count of at least 100,000 per cubic millimeter; aspartate
aminotransferase and alanine aminotransferase levels of 100 or less international unit per litter; a total bilirubin level of no more than 1.5 mg per deciliter; and a serum creatinine
level of no more than 1.2 mg per deciliter; a serum creatinine clearance level of no less than 50 mililitter per minutes; with a written informed consent for this study
Key exclusion criteria
The exclusion criteria were previously abdominal radiotherapy; active double cancers, with complication of paralytic intestine, bowel obstraction (ileus), uncontrolled diabtes mellitus, uncontrolled hypertention, unstable angina pectoris, liver cirrhosis, interstitial pneumonitis, pulmonary fibrosis or high-grade pulmonary emphysema; previous history of herpersensitivity against S-1; massive pleural or peritoneal effusion; diarrhea, uncontrolled peptic ulcer; current or previous (within one year) history of GI perforation; primary or metastatic brain tumor by image examination; current or previous (within one year) history of cerebrovascular attach; symptomatic or asymptomatic but treated heart disease; any surgical treatmentsincluding skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks (except for a CV-port procedure one week or more earlier) or aspiration biopsy within one week; bleeding tendency, coagulation abnormality; anti-platelets therapy (including aspirin and NSAIDS) for chronic inflammatory disease such as rheumatoid arthritis; irinotecan used pevious adjuvant chemotherapy
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chikashi Ishioka |
Organization
Institute of Development, Aging and Cancer, Tohoku University
Division name
Department of Clinical Oncology
Zip code
Address
4-1 Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan
TEL
022-717-8543
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunsuke Kato |
Organization
NPO T-CORE (Tohoku Clinical Oncology Research and Education Society)
Division name
Office
Zip code
Address
4-1 Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan
TEL
022-717-8599
Homepage URL
http://www.T-CORE.JP
t-core-admin@umin.ac.jp
Sponsor or person
Institute
NPO T-CORE (Tohoku Clinical Oncology Research and Education Society)
Institute
Department
Personal name
Funding Source
Organization
NPO T-CORE (Tohoku Clinical Oncology Research and Education Society)
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
| 2007 | Year | 07 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/22777333
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
| 2007 | Year | 06 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 07 | Month | 14 | Day |
Last modified on
| 2014 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000899
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| Registered date | File name |
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| Registered date | File name |
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