UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015098 |
|---|---|
| Receipt number | R000017566 |
| Scientific Title | Phase II study of S-1+CPT-11+Bevacizumab as second-line therapy in metastatic colorectal cancer which has prior therapy of S-1+L-OHP+Bevacizumab |
| Date of disclosure of the study information | 2014/09/09 |
| Last modified on | 2019/10/07 14:49:57 |
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Basic information
Public title
Phase II study of S-1+CPT-11+Bevacizumab as second-line therapy in metastatic colorectal cancer which has prior therapy of S-1+L-OHP+Bevacizumab
Acronym
Phase II study of IRIS+BV as second-line therapy in metastatic colorectal cancer which has prior therapy of SOX + BV
Scientific Title
Phase II study of S-1+CPT-11+Bevacizumab as second-line therapy in metastatic colorectal cancer which has prior therapy of S-1+L-OHP+Bevacizumab
Scientific Title:Acronym
Phase II study of IRIS+BV as second-line therapy in metastatic colorectal cancer which has prior therapy of SOX + BV
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of IRIS+Bevacizumab as second-line therapy in metastatic colorectal cancer which has prior therapy of SOX+Bmab
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
Key secondary outcomes
Response rate (RR)
Time to treatment failure (TTF)
Overall Survival (OS)
Safety profile
Relative dose intensity(RDI)
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
Bevacizumab 7.5mg/kg/tri-week
CPT-11 150mg/m2/tri-week
S-1 40-60mg/twice/day(day1-15)/tri-week
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.Histologically proven colorectal cancer (Adenocarcinoma)
2.Unresectable advanced/recurrent colorectal cancer
3. A measurable lesions in RECIST criteria is unnecessary
4. Metastatic colorectal cancer refractory to S-1, oxaliplatin, and Bmab therapy as first-line
5. Chemotherapy without 2 weeks before the initial administration of the study drug
6. Previously not treated radiotherapy for unresectable colorectal cancer
7. Aged 20-80 years at the time of registration
8. Performance status(ECOG) :0,1
9.Life expectancy estimated>=3 months
10.Adequate organ function
11. No abnormally electrocardiogram
12. Written IC
13. Able to receive oral treatment
Key exclusion criteria
1. History of serious drug hypersensitivity
2. Pregnant, lactating or women of
child-bearing potential. Men who want get partner pregnant.
3. Active infections 4.
4. Serious complications
5. Peptic ulcers
6. Over grade 2 diarrhea
7. Massive pleural effusion or ascites
8. Mechanical bowel obstruction
9. Symptomatic peritoneum dissemination
10. Brain metastasis
11. Current or previous (within the last 6 months) history of GI perforation
12. Hemoptysis
13. Previous history of thromboembolism, cerebral infarction, pulmonary infarction, interstitial pneumonia
14. Evidence of bleeding diathesis or coagulopathy
15. Ongoing treatment with anticoagulant or aspirin (> 325mg/day)
16. Administering transfusion within 14 days
17. Other active malignancies
18. Administration contraindication of 5-FU(Capecitabine, TS-1) Oxaliplatin, CPT-11 and Bevacizumab
19. Any other cases who are regarded as inadequate for study enrollment by the investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Kuwano |
Organization
Gunma University Graduate School
Division name
Department of General Surgical Science
Zip code
Address
3-39-22 Showa-machi, Maebashi-shi, Gunma
TEL
027-220-8224
hkuwano@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Soichi Tsutsumi |
Organization
Gunma University Graduate School
Division name
Department of General Surgical Science
Zip code
Address
3-39-22 Showa-machi, Maebashi-shi, Gunma
TEL
027-220-8224
Homepage URL
chuchumi@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Graduate School
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
| 2014 | Year | 09 | Month | 09 | 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
Completed
Date of protocol fixation
| 2013 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 09 | Day |
Last modified on
| 2019 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017566
