UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009734 |
|---|---|
| Receipt number | R000011411 |
| Scientific Title | Feasibility study of combination therapy with S-1 plus irinotecan in patients with EGFR positive KRAS mutation type unresectable colorectal cancer, who had previously received on irinotecan, oxaliplatin and fluoropyrimidine, bevacizumab |
| Date of disclosure of the study information | 2013/01/14 |
| Last modified on | 2022/01/17 07:41:08 |
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Basic information
Public title
Feasibility study of combination therapy with S-1 plus irinotecan in patients with EGFR positive KRAS mutation type unresectable colorectal cancer, who had previously received on irinotecan, oxaliplatin and fluoropyrimidine, bevacizumab
Acronym
Feasibility study of combination therapy with S-1 plus irinotecan in patients with EGFR positive KRAS mutation type unresectable colorectal cancer, who had previously received on irinotecan, oxaliplatin and fluoropyrimidine, bevacizumab
Scientific Title
Feasibility study of combination therapy with S-1 plus irinotecan in patients with EGFR positive KRAS mutation type unresectable colorectal cancer, who had previously received on irinotecan, oxaliplatin and fluoropyrimidine, bevacizumab
Scientific Title:Acronym
Feasibility study of combination therapy with S-1 plus irinotecan in patients with EGFR positive KRAS mutation type unresectable colorectal cancer, who had previously received on irinotecan, oxaliplatin and fluoropyrimidine, bevacizumab
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Medicine in general | Gastroenterology | Surgery in general |
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of S-1 plus irinotecan combination therapy in patients with EGFR positive KRAS mutaiton type unreseactable advanced/reccurent colorectal cancer, who had documented PD of 5FU based chemotherapy, and had received irinotecan and oxaliplatin, bevacizumab.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Progression free survival(PFS)
Key secondary outcomes
Overall response rate
Overall survival
Disease control rate (CR+PR+SD)
Safety
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
S-1/irinotecan combination therapy
Irinotecan 100 mg/m2(day1,15),
S-1 80-120mg/day, PO from day1 to day 14 of each 28 day cycle.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with histologically proven colorectal cancer and clinically proven unresectable advanced/recurrent colorectal cancer
2) KRAS mutation type
3) Age 20 years<= 80
4) Patients who had previously received on irinotecan, oxaliplatin and fluoropyrimidine,bevacizumab
5) ECOG performance status 0-1
6) Presence of measurable lesion judged by enhanced CT (according to the RECIST 1.1)
7) Patiens have enough organ function based on blood test within 28day before registration.
1.WBC>=3,000/mm3<=12,000/mm3 2.Neurtophils>=1,500/mm3
3. Platelets>=100,000/mm3
4. Hemoglobin>=9.0g/dl
5. Total bilirubin<=2.0mg/dl
6.AST<=100IU/L(ALT<=200IU/L with liver metastases)
7.ALT<=100IU/L(ALT<=200IU/L with liver metastases)
8. Creatinine<=1.2mg/dl
9. creatinine clearance>=50ml/min
8)Be able to take oral drugs
9)Life expectancy at least 3 months
10)Written informed consent
Key exclusion criteria
1) With contraindicate S-1
2) Patients under treatment with flucytosine,phenytoin,warfarin potassium.
3) Severe bone marrow suppression
4) Active infection and inflammation
5)Comorbidity or history of interstitial lung disease or pulmonary fibrosis
6) Watery stools or diarrhea
7) Severe complications
8)Simultaneous or metachronous double cancers
9)Pregnant or lactating women or women of childbearing potential
10) Other patients who are unfit for the study as determined by the attending physician
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiko Tsuchida |
Organization
Tokyo Medical University
Division name
3rd department of surgery
Zip code
Address
6-7-1 Nish-Shinjyuku Shinjyuku Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Kastumata |
Organization
Tokyo Medical University
Division name
3rd department of surgery
Zip code
Address
6-7-1 Nish-Shinjyuku Shinjyuku Tokyo
TEL
03-3342-6111
Homepage URL
k-katsu@tokyo-med.ac.jp
Sponsor or person
Institute
3rd department of surgery
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
None
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 14 | 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
| 2012 | Year | 10 | Month | 02 | Day |
Date of IRB
| 2012 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2012 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2022 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2022 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 09 | Day |
Last modified on
| 2022 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011411
