UMIN-CTR Clinical Trial

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
Email	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
Email	chuchumi@gunma-u.ac.jp

Sponsor
Institute	Gunma University Graduate School
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017566