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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005209
Receipt No. R000006142
Scientific Title A phase ll study of Capecitabine plus Bevacizumab therapy for advanced/recurrent colo-rectal cancer with difficulty on intensive chemotherapy (OGSG 1102)
Date of disclosure of the study information 2011/04/01
Last modified on 2020/09/16

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Basic information
Public title A phase ll study of Capecitabine plus Bevacizumab therapy for advanced/recurrent colo-rectal cancer with difficulty on intensive chemotherapy
(OGSG 1102)
Acronym A phase ll study of Capecitabine plus Bevacizumab therapy for advanced/recurrent colo-rectal cancer with difficulty on intensive chemotherapy
(OGSG 1102)
Scientific Title A phase ll study of Capecitabine plus Bevacizumab therapy for advanced/recurrent colo-rectal cancer with difficulty on intensive chemotherapy
(OGSG 1102)
Scientific Title:Acronym A phase ll study of Capecitabine plus Bevacizumab therapy for advanced/recurrent colo-rectal cancer with difficulty on intensive chemotherapy
(OGSG 1102)
Region
Japan

Condition
Condition colo-rectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To confirm the feasibility and effectiveness of Capefcitabine plus Bevacizumab therapy for advanced/recurrent colo-rectal cancer with difficulty on insentive chemotherapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Progression-free survival
Key secondary outcomes Response Rate(RECIST)
Disease controle rate
Overall survival
Adverse effect

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 Capevitabine plus Bevacizumab therapy
day1 : bevacizumab d.i.v.
day1 to 15 : Capecitabine p.o.
day16 to 21 : Capecitabine rest
repeat every 21 days
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) histologically proven colon cancer or rectal cancer
2) with mesurable lesions for RECIST criteria
3) without any chemotherapy berore (eligible if fluoro-pyrimidine treatment has completed more than 6 months before)
4) An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
5) rest period from former therapy
a) more than 4 weeks from an organ resection surgery
b) more than 4 weeks from hormone therapy or immune therapy
c) more than 4 weeks from cytocain or BRM therapy
6) without any severe complications and limited in the following data
a) neutrophile : 1,500/mm3 <=
b) hemoglobin : 9.0g/dl <=
c) platelet : 100,000/mm3 <=
d) T.bil. : 1.5mg/dl >=
e) AST, ALT : within 2.5 times of normal range of the hospital
f) creatinine : 1.2mg/dl >=
g) creatinine clearance >=30mL/min
male : [(140-age) x B.W.(kg)]/[72 x s-creatinine(mg/dl)]
female : [(140-age) x B.W(kg) x 0.85]/[0.72 x s-creatinine(mg/dl)]
7) patients expected more than 8 weeks survival
8) with written Informed Consent
9) age :
Group E : >= 76 years old
Group ID : >= 65 years old and with difficulty on intensive chemotherapy due to history of radiation therapy for the pelvic lesions, s-albumin lower than 3.5g/dl and/or doctors decision not to register to the other chemotherapy from intolerance to adverse events
Key exclusion criteria 1) with symptoms due to brain metastatis
2) with uncontrolable diarrhea
3) with difficulty on oral intake due to intestinal paralysis or obstruction
4) with infections diseases or febrile condition
5) with severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema etc)
6) with severe diseases (uncontrollable DM, heart failure severe than NYHA lll, renal failure, and/or hepatic failure)
7) pregnant and/or nursing women, or women who expect pregnancy
8) with metastatic meningitis, uncontrollable convulsion, and/or mental disorder
9) with a grade 3 neural disorder
10) with a condition intlerance to
medicines in this regimen
11) with a history of grade 3 allergy against Capecitabine
12) with a history of some chemotherapy and/or therapy including a VEGF antagonist
13) with a history of embolism, brain infraction (except Lacuna infraction) or pulmonary infraction
14) under easy bleeding condition due to some diseases or medicines (except low dose aspirin)
15) with a history of thoracic surgery of abdominal surgery 28 days ago
16) with active wounds except reservoir surgery
17) with a history of bloody spit more than 2.5ml
18) any other patient whom the physician in charge of the study judges to be unsuitable
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motoki Yoshida
Organization Osaka Medical College Hospital
Division name chemotherapy center
Zip code
Address 2-7,Daigakutyou,Takatsuk,City,Osaka
TEL 072-683-1221
Email motoyoshi@krmc.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Furukawa
Organization Kinki University School of Medicine
Division name Department of surgery
Zip code
Address 377-2, Onohigashi, Osakasayama, Osaka, Japan
TEL 072-366-0221
Homepage URL
Email hiroshi.furukawa@tokushukai.jp

Sponsor
Institute Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Institute
Department

Funding Source
Organization Osaka Clinical Study Supporting Organization
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 大阪医科大学(大阪府)、大阪市立総合医療センター(大阪府)、関西医科大学付属病院(大阪府)、関西労災病院(兵庫県)、慈泉会相澤病院(長野県)、大阪府立成人病センター(大阪府)、市立岸和田市民病院(大阪府)、市立貝塚病院(大阪府)、西宮市立中央病院(兵庫県)、まちだ胃腸病院(大阪府)

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 01 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
2011 Year 01 Month 21 Day
Date of IRB
2011 Year 05 Month 02 Day
Anticipated trial start date
2011 Year 07 Month 04 Day
Last follow-up date
2016 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2016 Year 11 Month 21 Day

Other
Other related information

Management information
Registered date
2011 Year 03 Month 07 Day
Last modified on
2020 Year 09 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006142

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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