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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010535
Receipt No. R000012274
Scientific Title Multicenter Phase II study of rechallenge Cetuximab plus Irinotecan in heavily pretreated Wild type KRAS metastatic Colorectal cancer
Date of disclosure of the study information 2013/04/18
Last modified on 2013/10/31

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Basic information
Public title Multicenter Phase II study of rechallenge Cetuximab plus Irinotecan in heavily pretreated Wild type KRAS metastatic Colorectal cancer
Acronym MARCH trial
Scientific Title Multicenter Phase II study of rechallenge Cetuximab plus Irinotecan in heavily pretreated Wild type KRAS metastatic Colorectal cancer
Scientific Title:Acronym MARCH trial
Region
Japan

Condition
Condition Metastatic colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of re-treatment Cetuximab and irinotecan for KRAS wild type metastatic colorectal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Overall Survival
Progression Free Survival
Safety
Response rate according to the prior Cetuximab regimen
Response rate according to the interval from prior Cetuximab treatment

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 Cetuximab + Irinotecan therapy

Cetuximab
Weekly schedule
400mg/(initial dose):250mg/m2(Maintenance dose) every week
or
Bi-weekly schedule
500mg/m2 every 2 weeks

Irinotecan
150mg/m2 every 2 weeks
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)Patients with histologically proven colorectal cancer
(2)KRAS wild type
(3)Metastatic colorectal cancer with measurable lesion(RECIST ver.1.1)
(4)Patients who were treated Cetuximab and the other regimen after Cetuximab (Exclude cetuxumab) for metastatic colorectal cancer.(Best response was more than stable disease with Cetuximab treatment.)
(5)Refractory to or intolerant of prior fluorinated pyrimidine , oxaliplatin and irinotecan.
(6)Age equal more 20 years old
(7)ECOG Performance Status 0-2
(8)Vital organ functions are preserved within 14 days prior to entry.
1)WBC:>=3,000/mm3
2)Neu:>=1,500/mm3
3)PLT:>=80,000/mm3
4)Hb:>=8.0g/dL
5)Total bilirubin:<=2.0mg/dL
6)AST,ALT:<=ULN*2.5(Patients with liver metastasis:<=ULN*5.0)
7)Serum creatinine:<=ULN*1.5
8)The Patient does not have electrocardiography abnormality to need treatment.
(9)Life expectancy of more than 3 months.
(10)Written informed consent.
Key exclusion criteria (1) Prior panitumumab treatment.
(2) Contraindications of irinotecan.
(3) Brain metastasis with symptom.
(4) Systemic infection.
(5) History of severe allergy.
(6) Active double cancer.
(7)Systemic administration of corticosteroids.
(8) Severe mental illness.
(9) Patients who are judged inappropriate for the entry into the study by the investigator.

Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mutsumi Fukunaga
Organization Sakai city hospital
Division name Cancer center
Zip code
Address Osaka-Prefecture,Sakai-City,Sakai-Ward Minami Yasui-cho 1-1-1
TEL 072-221-1700
Email fukunaga-m@sakai-hospital.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mutsumi Fukunaga
Organization Sakai city hospital
Division name Department of surgery
Zip code
Address Osaka-Prefecture,Sakai-City,Sakai-Ward Minami Yasui-cho 1-1-1
TEL 072-221-1700
Homepage URL
Email fukunaga-m@sakai-hospital.jp

Sponsor
Institute Sakai City Hospital
Institute
Department

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
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 大阪労災病院、りんくう総合医療センター

Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 18 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
2013 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 04 Month 18 Day
Last modified on
2013 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012274

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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