UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized phase 2 study of mFOLFOX6 plus bevacizumab versus modified OPTIMOX plus bevacizumab for metastatic colorectal cancer
Title of the study (Brief title)	Randomized phase 2 study of mFOLFOX6 plus bevacizumab versus modified OPTIMOX plus bevacizumab for metastatic colorectal cancer
Region	Japan

Condition
Condition	colorectal cancer
Classification by specialty	Gastroenterology Hematology and clinical oncology Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate safety and efficacy of first-line mFOLFOX6 plus bevacizumab and modified OPTIMOX plus bevacizumab for patients with unresectable colorectal cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	disease control survival
Key secondary outcomes	Progression-free survival Overall survival The incidence of adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	After 8 cycles of mFOLFOX 6 plus bevacizumab, patients receive UFT/LV with bevacizumab (until 5 cycles are completed or disease progression). And then, patients receive modified FOLFOX6 plus bevacizumab until disease progression.
Interventions/Control_2	Patients receive mFOLFOX6 plus bevacizumab until disease progression.
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1) unresectable or recurrent colorectal cancer histologically diagnosted adenocarcinoma of the colon or rectum. 2) Age more than 20years and less than 75 years. 3) No prior therapies for metastatic and/or recurrent disease. Prior adjuvant therapy is allowed if it is completed at least 6 months before registration. 4) ECOG performance status of 0 or 1 . 5) Required baseline laboratory parameters (within 7 days before registration): WBC more than 4000 and WBC less than 12000/mm3 Neutrophils more than 2000/mm3 Plt more than 100,000/mm3 Hb more than 9.0g/dl GOT less than 100 IU/l GPT less than 100 IU/l T-Bil less than 1.5mg/dl Creatinine less than 1.5mg/dl 6) Signed informed consent of the patient for the registration.
Key exclusion criteria	1) contraindication to 5-FU, oxaliplatin, UFT, calcium folinate, or bevacizumab. 2) moderate/severe pleural effusion, ascites or pericardial effusion. 3) brain metastases. 4) history of active other malignancies. 5) neuropathy. 6) history of thoromboembolitic disease. 7) uncontrollable Diabetes Mellitus or hypertension 8) interstitial lung disease, pulmonary fibrosis or severe pulmonary emphysema. 9) intestinal bleeding, ileus, bowel obstruction or uncontrolled peptic ulcer. 10) clinically significant infectious disease (body temperature more than 38.0 degrees) 11) urinary protein (more than 1+) 12) uncontrolled watery diarrhea. 13) pregnant or lactating women, women who are capable of pregnancy or intend to get pregnant. 14) Any other cases who are regarded as inadequate for study enrollment by the attending doctors.
Target sample size	80

Research contact person
Name of lead principal investigator	Tadamichi Denda
Organization	Chiba Cancer Center
Division name	Gastroenterology
Address	666-2, Nitona-cho, Chuo-ku, Chiba city, Chiba, Japan
TEL	043-264-5431
Email	tdenda@chiba-cc.jp

Public contact
Name of contact person	Tadamichi Denda
Organization	Chiba Cancer Center Hospital
Division name	Gastroenterology
Address	666-2, Nitona-cho, Chuo-ku, Chiba city, Chiba, Japan
TEL	043-264-5431
Homepage URL
Email	tdenda@chiba-cc.jp

Sponsor
Institute	Chiba Cancer Center Hospital
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)

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	2010 Year 04 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 06 Month 24 Day
Anticipated trial start date	2008 Year 07 Month 01 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	2010 Year 04 Month 12 Day
Last modified on	2017 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004207