UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II study of combination chemotherapy of oral tegafur/uracil, leucovorin and bevacizumab for patients not appropriate for intensive therapy with unresectable or recurrent colorectal cancer
Title of the study (Brief title)	A phase II study of UFT/LV and bevacizumab treatment
Region	Japan

Condition
Condition	unresectable metastatic/recurrent colorectal cancer
Classification by specialty	Gastroenterology Hematology and clinical oncology Surgery in general Gastrointestinal surgery Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We investigated the efficacy and safety of combination therapy of UFT/LV and Bevacizumab for patients not appropriate for intensive therapy with unresectable or recurrent colorectal cancer.
Basic objectives2	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	Overall survival, Time to treatment failure, Overall response rate, Disease control rate, Adverese

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	UFT(300mg/m2/day) and LV(75mg/day) are simultaneously given 3times per day for 5days, followed by 2-day rest. Bevacizumab is administerd by every 3 weeks.
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 histologically verified adenocarcinoma of the colon and rectum 2) Patients with Unresectable metastatic/recurrent colorectal cancer 3) Patients not appropriate for intensive therapy, such as FOLFOX or FOLFIRI 4) Patents without a previous chemotherapy or radiation therapy 5) Patient's age over 20 years-old 6) ECOG Performance status of 0-2 adequate bone marrow, liver, renal, and cardiac function; no prior radiotherapy, chemotherapy or any molecular targeting therapy for rectal cancer; ; no severe concurrent medical or psychiatric illness; no a known hypersensitivity to the study drugs; and none of the patients were pregnant or lactating.
Key exclusion criteria	1)Patients with a past history of severe drug allergy 2)no other co-existing malignancy or malignancy within the last five years prior to enrollment other than non-melanoma skin cancer or in situ carcinoma of the cervix 3)patients were pregnant or lactating 4)Patients with psychiatric illness 5)Patients with severe co-morbidities (renal failure, liver dysfunction, uncontrolable diabetes mellitus and hypertension, heart failure) 6)Patients with massive ascites or hydrothorax 7)Patients with a symptomatic brain metastasis 8)Patients with abdominal surgery within 28days 9)Patients with perforated disease 10)Patients with thrombosis 11)Patiens with 3+ proteinurea
Target sample size	35

Research contact person
Name of lead principal investigator	Kiyoshi Maeda
Organization	Osaka City University Graduate School of Medicine
Division name	Dept of Surgical Oncology
Address	Asahimachi, Abeno-ku, Osaka
TEL	06-6645-3838
Email	m1378386@med.osaka-cu.ac.jp

Public contact
Name of contact person	Kiyoshi Maeda
Organization	Osaka City University Graduate School of Medicine
Division name	Dept of Surgical Oncology
Address	Asahimachi, Abeno-ku, Osaka
TEL	06-6645-3838
Homepage URL
Email	m1378386@med.osaka-cu.ac.jp

Sponsor
Institute	Dept of Surgical Oncology Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Dept of Surgical Oncology Osaka City University Graduate School of Medicine
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 10 Month 07 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 09 Month 23 Day
Anticipated trial start date	2016 Year 09 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	2016 Year 10 Month 07 Day
Last modified on	2016 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=R000027804