UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001794 |
|---|---|
| Receipt number | 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 18:24:23 |
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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
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
hkusaba@intmed1.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu Medical Oncology Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002164
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