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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002695
Receipt No. R000003288
Scientific Title Randomized phase II study of CPT-11 plus TS-1 plus Cetuximab for advanced and/or recurrent colon cancer which are oxaliplatin-resistant and KRAS wild type
Date of disclosure of the study information 2009/10/31
Last modified on 2011/06/03

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Basic information
Public title Randomized phase II study of CPT-11 plus TS-1 plus Cetuximab for advanced and/or recurrent colon cancer which are oxaliplatin-resistant and KRAS wild type
Acronym OGSG 0901
Scientific Title Randomized phase II study of CPT-11 plus TS-1 plus Cetuximab for advanced and/or recurrent colon cancer which are oxaliplatin-resistant and KRAS wild type
Scientific Title:Acronym OGSG 0901
Region
Japan

Condition
Condition advanced and/or recurrent colon cancer which are oxaliplatin-resistant and KRAS wild type
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To confirm the feasibility and effectiveness of CPT-11 plus TS-1 plus Cetuximab for advanced and/or recurrent colon cancer which are oxaliplatin-resistant and KRAS wild type
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Response Rate(RECIST)
Key secondary outcomes 1)survival time
2)Time to progression
3)Ratio controling the tumor
4)Adverse events
5)Incidence of skin illness in grade 2-3

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 <Administration schedule>
One couese takes 28 days.
TS-1:TS-1(14days),interval(14days)
CPT-11:Day1,Day15,Day29
Cetuximab:Day1,Day8,Day15,Day22,Day29
TS-1:80mg/m2
CPT-11:100mg/m2
Cetuximab:only one couse (400mg/m2)
two couse after (250mg/m2)
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Histologically proven colon cancer or rectal cancer
2) genetically proven KRAS wild type of the tumor tissue
3) with measurable lesions for RECIST criteria
4) Patients with tumor resistant to oxaliplatin after one or more courses of oxaliplatin treatment and without treatments including CPT-11 and/or Cetuximab
5) patients older than 20 years
6) An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 1, 2 or less.
7) A predicted life expectancy of at least 3 months.
8) with prior chemotherapy completed before more than 20 days
9) with normal function of the important organs
10) Ability of oral intake
11) Written informed consent to participate in this study
Key exclusion criteria 1) with treatments including CPT-11 and/or Cetuximab
2) with active double cancers
3) Any other serious illness or medical condition(s) including ileus, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, heart failure, renal failure, liver failure, etc.
4) Infectious disease
5) Diarrhea (watery stools)
6) with obstruction or disorder on digestive tract due to peritoneal metastasis
7) with ascites and/or pleural fluid
8) History of serious drug hypersensitivity
9) Undergoing anti-fungal treatment with fluorocytosine, or atazanavir sulfate.
10) Found to have fresh gastrointestinal bleeding that requires repeated transfusion.
11) With liver cirrhosis or jaundice.
12) patients undergoing treatment with a psychotropic agent or who have a mental disorder that seems to require treatment.
13) having heart disease, such as ischemic heart disease or an arrhythmia, which require treatment.
14) With diabetes that is difficult to control.
15) With central nervous system metastasis
16) women pregnant, breast-feeding, or who wish pregnancy
17) Any other patient whom the physician in charge of the study judges to be unsuitable
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name sakai daisuke
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Dpt.Tumor psychiatry
Zip code
Address 1-3-3, nakamichi,higashinari-ku,osaka
TEL 06-6972-1181
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Sakai City Hospital
Division name Dpt.Surgery
Zip code
Address
TEL
Homepage URL
Email

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

Other administrative information
Date of disclosure of the study information
2009 Year 10 Month 31 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 Open public recruiting
Date of protocol fixation
2009 Year 10 Month 26 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2015 Year 03 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 10 Month 31 Day
Last modified on
2011 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003288

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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