UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005209
Receipt number 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 21:47:52

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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 or person

Institute

Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)

Institute

Department

Personal name



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

Value
https://center6.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