UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008850 |
|---|---|
| Receipt number | R000010390 |
| Scientific Title | Randomized Phase II Study of BSC vs Cetuximab vs Irinotecan and Cetuximab in Patients with KRAS codon G13D mutant Metastatic Colorectal Cancer (G13 study) |
| Date of disclosure of the study information | 2012/09/04 |
| Last modified on | 2018/09/20 08:25:35 |
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Basic information
Public title
Randomized Phase II Study of BSC vs Cetuximab vs Irinotecan and Cetuximab in Patients with KRAS codon G13D mutant Metastatic Colorectal Cancer (G13 study)
Acronym
G13 study
Scientific Title
Randomized Phase II Study of BSC vs Cetuximab vs Irinotecan and Cetuximab in Patients with KRAS codon G13D mutant Metastatic Colorectal Cancer (G13 study)
Scientific Title:Acronym
G13 study
Region
| Japan |
Condition
Condition
Metastatic colorectal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the efficacy and safety of BSC, Cetuximab monothrapy versus Cetuximab + Irinotecan in patients with EGFR-detectable and KRAS G13D mutant metastatic colorectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Progression Free Survival
Key secondary outcomes
Overall Response Rate, Response Rate by metastatic site, Disease Control Rate, Overall Survival, Safety.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Cetuximab
Interventions/Control_2
Cetuximab+Irinotecan
Interventions/Control_3
BSC
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 confirmed colorectal cancer.
(2) Metastatic colorectal cancer with EGFR.
(3) KRAS codon G13D mutation.
(4) Failed prior regimen containing irinotecan.
(5) Age over 20 years.
(6) ECOG Performance Status 0-2.
(7) Measurable lesion based on RECIST
ver1.1.
(8) Adequate organ function for study treatment.
(9) A life expectancy of more than 3 months.
(10) Written informed consent.
Key exclusion criteria
(1) Severe myelosupression.
(2) Severe infection.
(3) Uncontrolled diarrhea.
(4) Pleural effusion, ascites and pericardial fluid.
(5) Serious heart disease.
(6) Intestinal lung disease or pulmonary fibrosis.
(7) Bowel obstruction.
(8) Jaundice.
(9) Receiving Atazanavir Sulfate.
(10) History of severe allergy.
(11) Allergy for irinotecan.
(12) Pregnant or possibly pregnant, and nursing women.
(13) Severe comorbidity(renal failure, hepatic failure, hypertension, hypercalcemia)
(14) Symptomatic brain metastases.
(15) multiple malignancies.
(16) Other conditions not suitable for this study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideyuki Mishima |
Organization
Aichi Medical University
Division name
Cancer Center
Zip code
Address
1-1 Yazakokarimata, Nagakute, Aichi
TEL
0561-62-3311
hmishima@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yumi Miyashita |
Organization
Epidemiological and Clinical research Information Network (ECRIN)
Division name
Aichi branch
Zip code
Address
1-7-9 Hanenishi, Okazaki, Aichi, JAPAN
TEL
052-744-2442
Homepage URL
miya@ecrin.or.jp
Sponsor or person
Institute
Epidemiological and Clinical research Information Network (ECRIN)
Institute
Department
Personal name
Funding Source
Organization
Epidemiological and Clinical research Information Network (ECRIN)
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2012 | Year | 09 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5225170/pdf/280_2016_Article_3203.pdf
Number of participants that the trial has enrolled
Results
Randomized phase II study of cetuximab versus irinotecan and cetuximab in patients with chemo-refractory KRAS codon G13D metastatic colorectal cancer (G13D-study).
Nakamura M, Aoyama T, Ishibashi K, Tsuji A, Takinishi Y, Shindo Y, Sakamoto J, Oba K, Mishima H.
Cancer Chemother Pharmacol. 2017 Jan;79(1):29-36.
RESULTS:
Data from a total of 29 patients (10 in Cet group, 19 in CetI group) were analyzed. Crude median progression-free survival time was 2.9 months in the Cet group and 2.5 months in the CetI group. Crude disease control rates were 55.6% in the Cet group and 47.4% in the CetI group. After a median follow-up of 43 months, the crude median overall survival was 8.0 months in the Cet group and 7.6 months in the CetI group. Cetuximab-based treatment did not markedly increase any characteristic toxicity and was generally well tolerated. Propensity score analyses adjusted for performance status and number of metastases showed comparable results with the crude 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
| 2012 | Year | 05 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 05 | Month | 02 | Day |
Date trial data considered complete
| 2016 | Year | 05 | Month | 06 | Day |
Date analysis concluded
| 2016 | Year | 11 | Month | 03 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 04 | Day |
Last modified on
| 2018 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010390
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