UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000613
Receipt number R000000741
Scientific Title Phase II study of a combination of CPT-11, 5FU/l-LV and UFT/LV in patients with advanced/recurrent colorectal cancer
Date of disclosure of the study information 2007/03/01
Last modified on 2009/12/04 17:37:15

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Basic information

Public title

Phase II study of a combination of CPT-11, 5FU/l-LV and UFT/LV in patients with advanced/recurrent colorectal cancer

Acronym

OGSG0605

Scientific Title

Phase II study of a combination of CPT-11, 5FU/l-LV and UFT/LV in patients with advanced/recurrent colorectal cancer

Scientific Title:Acronym

OGSG0605

Region

Japan


Condition

Condition

advanced/recurrent colorectal cancer

Classification by specialty

Gastroenterology Hematology and clinical oncology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Phase II study of a combination of CPT-11,5-FU/l-LV and UFT/LV in patients with advanced/recurrent colorectal cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

response rate

Key secondary outcomes

adverse events, overall survival,progression-free survival,time to treatment failure.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

It takes 2 weeks for one course and that is to be repeated.
Dose schedule for one course
CPT-11 150mg/ m2/day Day 1
5-FU 500 mg/m2/day Day 1
l-LV 15 mg/m2/day Day 1
UFT 300 mg/m2/day Day 1-8 morning
LV 75 mg/day Day 1-8 morning

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) diagnosed as colon cancer
pathologically
2)with measurable lesions
3)without prior chemotherapy
4)without prior radiation therapy
5)20 years old <= => 75 years old
6)Performance status: 0 &#8211; 1 (ECOG)
7)Expected survival more than 12 weeks
8)Within labo. data level written,
subsequently
WBC >= 4,000/mm3 and <= 12,000/mm3
Neutrocyte >= 2,000/mm3
Platelet >= 100,000/mm3
sGOT, sGPT <upper limit of each
institute x 2.5
sBil <= 2.0mg/dl
creatinin <= upper limit of each
institute
Normal ECG
9)Informed Consents with written form
10) Patients who can take orally

Key exclusion criteria

1)interstitial pneumonitis or pulmonary
fibrosis
2)with cavity fluid to be treated
3)with present active double cancer or
D.B. diagnosed less than 5 years
before, excluding cured cancer in situ
or skin cancer
4)ileus
5)watery diarrhea
6)D.M. which needs insulin or
uncontrolled D.M.
7)With other diseases which influence
to the study (heart diseases, liver
dysfunction, renal failure)
8)brain metastasis with some symptoms
9)pregnant women or suspected women
10)receiving atazanavir sulfate
11)Receiving steroids treatment
12)With experience of drug anaphylaxis
shock
13)Doctor stop due to miscellaneous
factors

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name TAMURA TAKAO

Organization

KOBE UNIVEISITY

Division name

Dpt.Digestive Diseases

Zip code


Address

7-5-1,Ksunokicho,Chuoku,Kobe 650-0017

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

OGSG

Division name

Office

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)

Institute

Department

Personal name



Funding Source

Organization

NPO Osaka Chinical 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



Other administrative information

Date of disclosure of the study information

2007 Year 03 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

Terminated

Date of protocol fixation

2007 Year 01 Month 23 Day

Date of IRB


Anticipated trial start date

2007 Year 02 Month 01 Day

Last follow-up date

2009 Year 02 Month 01 Day

Date of closure to data entry

2009 Year 02 Month 01 Day

Date trial data considered complete

2009 Year 02 Month 01 Day

Date analysis concluded

2009 Year 02 Month 01 Day


Other

Other related information



Management information

Registered date

2007 Year 02 Month 19 Day

Last modified on

2009 Year 12 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000741


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name