UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010535 |
|---|---|
| Receipt number | 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 | 2023/04/25 17:30:14 |
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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 | Mutsumi |
| Middle name | |
| Last name | Fukunaga |
Organization
Hyogo Prefectural Nishinomiya Hospital
Division name
Department of Surgery
Zip code
662-0918
Address
Hyogo-prefecture, 13-9 Rokutanjicho, Nishinomiya-city
TEL
0798-34-5151
fukunaga1404@hp.pref.hyogo.jp
Public contact
Name of contact person
| 1st name | Mutsumi |
| Middle name | |
| Last name | Fukunaga |
Organization
Hyogo Prefectural Nishinomiya Hospital
Division name
Department of surgery
Zip code
662-0918
Address
Hyogo-Prefecture, 13-9 Rokutanjicho, Nishinomiya-City
TEL
0798-34-5151
Homepage URL
fukunaga1404@hp.pref.hyogo.jp
Sponsor or person
Institute
Hyogo Prefectural Nishinomiya Hospital
Institute
Department
Personal name
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
Sakai City Medical Center
Address
Osaka-Prefecture, 1-1-1 Ebaraji-cho, Nishi-ku, Sakai City
Tel
072-272-1199
chikenkanri@sakai-hospital.jp
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
0
Results
Canceled halfway.
Results date posted
| 2023 | Year | 04 | Month | 25 | Day |
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
| 2013 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2013 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 18 | Day |
Last modified on
| 2023 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012274
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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