UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II study of TFTD plus Bevacizumab in patients with unresectable advanced colorectal cancer
Title of the study (Brief title)	TFTD plus Bmab for unresectable colorectal cancer
Region	Japan

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

Objectives
Narrative objectives1	To evaluate time to treatment failure of TFTD plus Bevacizumab therapy for unresectable advanced colorectal cancer
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Time to treatment failure
Key secondary outcomes	Safety and efficacy

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	TFTD: fixed dose Bevacizumab: fixed dose
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	Patients who satisfy all the following criteria are enrolled. 1. Unresectable or recurrent colorectal cancer patients confirmed histopathologically as colorectal cancer. 2. It does not have treatment history by TFTD (Lonsurf) and meets one of the following criteria. 5-FU, L-OHP, CPT-11 already treated 5-FU, L-OHP, CPT-11 unacceptable Cases who cannot performed for strong treatment. 3. Lesions can be confirmed by image examination within 28 days before registration (measurable lesions are not essential) 4. Performance status (ECOG): 0 to 2 cases. 5. Age >=20 6. A case expected more than 3 months from the administration start date. 7. Case where clinical laboratory test values satisfy all of the following conditions (latest inspection value within 14 days before registration) [Hematology test value] White blood cell count >= 3,000 / mm 3, and <= 12,000 mm 3 Number of neutrophils >= 1,500 / mm 3 Number of platelets >= 100,000 / mm 3 Hemoglobin >= 8.0 g / dl [Liver function test value] AST (GOT), ALT (GPT) <= 100 U / l (200 U / l in cases of liver metastasis) or less [Renal function test value] Serum creatinine <= 1.50 mg / dL 8. Patients with test urine or normal urinalysis with proteinuria less than 1+ (24 hours of urine storage when test urine or 2 >= 2 + proteinuria in normal urinalysis, urine protein 1000 mg can participate if it is less than) 9. Patients without blood transfusion within 14 days before registration 10. Patients who has written informed consent.
Key exclusion criteria	Patients who conflict with one of the following will not be included in this clinical study. 1. Patients with simultaneous active malignant disease. 2. Patients who had history of deep vein thrombosis, pulmonary embolism, or other significant thromboembolic disorder (thrombosis of the venous port or catheter or superficial venous thrombosis is not considered serious). 3. Patients with serious bleeding disorder, vasculitis, or serious gastrointestinal bleeding within 3 months before acquiring consent. 4. Patients with gastrointestinal perforation and / or history of fistula. 5. Patients with a history of pulmonary hemorrhage (hemoptysis). 6. Despite standard medical management, patients with uncontrollable arterial hypertension. 7. Patients with serious or unrecovered wounds, a history of peptic ulcer or fracture. 8. Patients with bowel obstruction, complication of inflammatory bowel disease or extensive intestinal resection, patients with Crohn's disease, ulcerative colon or chronic diarrhea. 9. Patients with serious drug allergy. 10. Patients with infection with fever over 38.0. 11. Patients with double active cancers which mean synchronous double cancers or metachronous double cancers with a disease-free period within 5 years. 12. Patients with brain metastasis. 13. Patients with severe complications such as the following. Patients with complications of infection during antibiotic administration. Patients with complications of treatment or poor control due to continued use of insulin. Patients of complication of hypertension with poor control. Patients with myocardial infarction that developed within 6 months. Patients with unstable angina. Patients in which liver cirrhosis was complicated. Patients in which interstitial pneumonia and pulmonary fibrosis are complicated. 14. Pregnant or nursing female. 15. Patient with mental illness. 16. Not appropriate for the study at the physician's assessment.
Target sample size	45

Research contact person
Name of lead principal investigator	Hiroaki Nagano
Organization	Yamaguchi University Graduate School of Medicine
Division name	Department of Gastroenterological, Breast and Endocrine Surgery
Address	1-1-1 Minamikogushi, Ube, Yamaguchi 755-8505, Japan
TEL	0836-22-2264
Email	hnagano@yamaguchi-u.ac.jp

Public contact
Name of contact person	Nobuaki Suzuki
Organization	Yamaguchi University Graduate School of Medicine
Division name	Department of Gastroenterological, Breast and Endocrine Surgery
Address	1-1-1 Minamikogushi, Ube, Yamaguchi 755-8505, Japan
TEL	0836-22-2264
Homepage URL
Email	nobusuzu@yamaguchi-u.ac.jp

Sponsor
Institute	Department of Gastroenterological, Breast and Endocrine Surgery,Yamaguchi University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Gastroenterological, Breast and Endocrine Surgery,Yamaguchi University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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	2019 Year 01 Month 23 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 12 Month 12 Day
Anticipated trial start date	2018 Year 12 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2019 Year 01 Month 23 Day
Last modified on	2019 Year 01 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040531