UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002378 |
|---|---|
| Receipt number | R000002912 |
| 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. |
| Date of disclosure of the study information | 2009/08/28 |
| Last modified on | 2019/12/19 15:47:01 |
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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
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
Sponsor or person
Institute
Japan South West Oncology Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002912
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