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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000770
Receipt No. 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

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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
Email

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
Email t-core-admin@umin.ac.jp

Sponsor
Institute NPO T-CORE (Tohoku Clinical Oncology Research and Education Society)
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000899

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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