UMIN-CTR Clinical Trial

Basic information
Public title	Safety and efficacy of FOLFOX plus bevacizumab or FOLFIRI plus bevacizumab as second line Therapy in Advanced colorectal Cancer previously treated with bevacizumab.
Acronym	JSWOG0901
Scientific Title	Safety and efficacy of FOLFOX plus bevacizumab or FOLFIRI plus bevacizumab as second line Therapy in Advanced colorectal Cancer previously treated with bevacizumab.
Scientific Title:Acronym	JSWOG0901
Region	Japan

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

Objectives
Narrative objectives1	Safety and efficacy of FOLFOX plus bevacizumab or FOLFIRI plus bevacizumab as second line Therapy in Advanced colorectal Cancer previously treated with bevacizumab.
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	.Overall survival from first line .Second progression free survival (progression free survival from first line) .Response rate .Time to treatment failure .Safety

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	FOLFOX plus bevacizumab or FOLFIRI plus bevacizumab is treated until progression.
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) disease progression (PD) determined via clinical and/or radiographic assessment after chemotherapy with bevacizumab as 1st line (PD according to RECIST criteria/with measurable lesions) (2) colorectal cancer, cytologically and/or histrogically (3) witten informed consents (4) age: 20-75 years old (5) Performance Status(ECOG):0-1 (6) Life expectancy estimated >= 3 months (7) Sufficient organ functions
Key exclusion criteria	(1) Administering transfusion/hematopoietic factor or antithrombotic drug within 14 days (2) Serious renal complications (3) Serious drug hypersensitivity or a history of drug allergy (4) Peripheral neuropathy (5) Active concomitant malignancy (6) Active infections (7) High blood pressure and diabetic that cannot be controlled (8) symptomatic or asymptomatic but treated heart disease (9) interstitial pnumonitis, pulmonary fibrosis or high-grade pulmonary emphysema (10) Traumatic fracture of unrecovery (11) history of mental disturbances or cerebrovascular accident (12) Fresh hemorrhage from digestive tube, intestines tube paralysis, intestinal obstruction and peptic ulcer (13) Current or previous (within one year) history of GI perforation (14) Pleural effusion, peritoneal fluid and pericardial fluid (15) Symptomatic brain metastasis (16) uncontrolled diarrhea (17) Any surgical treatments including skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week (18) Anti-platelets therapy (including aspirin and NSAIDS) (19) Need to treatment with atazanavir sulfate (20) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers (21) bleeding tendency(including hemoptysis) or coagulation disorder (22) Other conditions not suitable for this study
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masazumi Okajima
Organization	Hiroshima University
Division name	Department of Endoscopic Surgery and Surgical Science,
Zip code
Address	Kasumi 1-2-3, Minami-ku, Hiroshima, 734-8551
TEL	082-257-5222
Email

Public contact
Name of contact person	1st name Middle name Last name Satoshi Ikeda
Organization	Hiroshima University
Division name	Department of Endoscopic Surgery and Surgical Science,
Zip code
Address	Kasumi 1-2-3, Minami-ku, Hiroshima, 734-8551
TEL	082-257-5222
Homepage URL
Email

Sponsor
Institute	Japan South West Oncology Group
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	2009 Year 08 Month 28 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	2009 Year 01 Month 01 Day
Date of IRB	2009 Year 02 Month 13 Day
Anticipated trial start date	2009 Year 01 Month 01 Day
Last follow-up date	2011 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2009 Year 08 Month 25 Day
Last modified on	2019 Year 12 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002912