UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II study for the safety and efficacy of TAS-102 and Bevacizumab for patients with unresectable colorectal cancer considering Oxaliplatin to stop and go.
Title of the study (Brief title)	A phase II study for the safety and efficacy of TAS-102 and Bevacizumab for patients with unresectable colorectal cancer considering Oxaliplatin to stop and go.
Region	Japan

Condition
Condition	unresectable colorectal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	A phase II study for the safety and efficacy of TAS-102 and Bevacizumab for patients with unresectable colorectal cancer considering OPTIMOX.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	PFS: Progression-free survival
Key secondary outcomes

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	TAS-102+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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients with unresectable advanced/relapsed colorectal cancer. 2. Aged over 20 at the time of informed consent. 3. ECOG performance status (PS) of 0 to 2 4. Patients with lesion(s) that can be evaluated and it should be confirmed by CT, MRI, X-ray. 5. The cases without a history of chemotherapy but possible to register if over 180 days have been passed since the last day of postoperative adjuvant chemotherapy. 6. Oral intake 7. Major organ functions are maintained by a laboratory study. 8. The cases could survive at least for 3 months from the registration day. 9. IC is obtained in a document from the patients.
Key exclusion criteria	1. The cases with serious drug hypersensitivity or allergy. 2. Pregnant or men who expect the partner's pregnancy. 3. The cases with infectious disease requiring systemic therapy. 4. The cases with serious complications - Interstitial pneumonia, pulmonary fibrosis - Heart failure - Renal failure - Liver failure - Poor control diabetes mellitus - Poor control high blood pressure 5. Cases with ECG abnormalities are found or heart disease as a clinical problem , ( heart failure , myocardial infarction , angina pectoris). 6. Cases with gastrointestinal ulceration or bleeding. 7. Pre-existing with hemoptysis. 8. Cases with peripheral nerve disorder. 9. Patients who need a treatment for abdominal dropsy and pleural effusion. 10. Possibility of brain metastasis. 11. Perforation of the digestive tract within 6 months from the day of registration. 12. Pre-existing with thromboembolism, cerebral infarction, lung infarction and pneumonitis. 13. Surgery within 28 days from the registration day. 14. Bleeding tendency 15. Multiple primary cancers 16. Constitutional administration therapy with steroid 17. The cases judged to be unsuitable for registration. 18. Primary lesion with stricture 19. Cases with peritoneal metastasis
Target sample size	45

Research contact person
Name of lead principal investigator	Soichi Tsutsumi
Organization	Gunma University Hospital
Division name	Integrative Center of General Surgery
Address	3-39-15 Showa-machi Maebashi Gunma 371-8511
TEL	027-220-8224
Email	chuchumi@gunma-u.ac.jp

Public contact
Name of contact person	Kyoichi Kaira
Organization	Gunma University Graduate School of Medicine
Division name	Department of Oncology Clinical Development
Address	3-39-22 Showa-machi Maebashi Gunma 371-8511
TEL	027-220-8222
Homepage URL
Email	kkaira1970@yahoo.co.jp

Sponsor
Institute	Gunma University
Institute
Department

Funding Source
Organization	Gunma University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 05 Month 31 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 05 Month 16 Day
Anticipated trial start date	2015 Year 05 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 01 Month 17 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 05 Month 30 Day
Last modified on	2018 Year 01 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025919