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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000001794
Receipt No. R000002164
Scientific Title Phase II study of Irinotecan, TS-1 and Bevacizumab as second-line treatment in patients with advanced colorectal cancer (KMOG 0708)
Date of disclosure of the study information 2009/03/26
Last modified on 2015/09/26

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Basic information
Public title Phase II study of Irinotecan, TS-1 and Bevacizumab as second-line treatment in patients with advanced colorectal cancer (KMOG 0708)
Acronym Phase II study of Irinotecan, TS-1 and Bevacizumab as second-line treatment in patients with advanced colorectal cancer
Scientific Title Phase II study of Irinotecan, TS-1 and Bevacizumab as second-line treatment in patients with advanced colorectal cancer (KMOG 0708)
Scientific Title:Acronym Phase II study of Irinotecan, TS-1 and Bevacizumab as second-line treatment in patients with advanced colorectal cancer
Region
Japan

Condition
Condition advanced colorectal cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of TS-1 , irinotecan and Bevacizumab in patients with advanced colorectal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response Rate
Key secondary outcomes Safety, Overall survival, Progression free survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 TS-1+CPT-11+Bevacizumab
Interventions/Control_2
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 (1) Histological confirmation of colorectal cancer
(2) Advanced colorectal cancer
(3) Measurable disease
(4) refractory for 1st-line chemotherapy
(5) ECOG-PS:0-2
(6) Adequate major organ function
(7) All patients provided written informed consent
Key exclusion criteria (1) Massive pleural effusion or massive ascites
(2) Symptomatic brain metastases
(3) Active diarrhea
(4) Active bleeding
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eishi Baba
Organization Kyushu University Hospital
Division name Division of Hematology and Oncology
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka812-8582, Japan
TEL 092-642-5232
Email e-baba@intmed1.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hitoshi Kusaba
Organization Kyushu University Hospital
Division name Division of Hematology and Oncology
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka812-8582, Japan
TEL 092-642-5232
Homepage URL
Email hkusaba@intmed1.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu Medical Oncology Group
Institute
Department

Funding Source
Organization Kyushu Medical 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
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 九州大学病院(福岡県)

Other administrative information
Date of disclosure of the study information
2009 Year 03 Month 26 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Fourteen patients were enrolled in phase I of the study between January 2008 and September 2010. Dose-limiting toxicities (DLT) were diarrhea, abdominal pain, and infection. DLTs were observed in 5 out of 8 patients in Level 1 and 1 out of 6 patients in Level -1. The MTD and RD of BV were determined to be 10 mg/kg and 7.5 mg/kg, respectively. The main adverse events were leukopenia, neutropenia, anorexia, and diarrhea. An independent review committee was scheduled to evaluate safety in phase I, but this trial closed early due to toxicity. This study identified the risk of gastrointestinal toxicity with the combination of irinotecan and S-1 plus BV as second-line chemotherapy in patients with advanced colorectal cancer. (H Kusaba et al.Cancer Chemother Pharmacol.71(1):29-34,2013)
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 Main results already published
Date of protocol fixation
2007 Year 10 Month 28 Day
Date of IRB
Anticipated trial start date
2008 Year 01 Month 01 Day
Last follow-up date
2011 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2011 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 03 Month 24 Day
Last modified on
2015 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002164

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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