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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008850
Receipt No. 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

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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
Email 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
Email miya@ecrin.or.jp

Sponsor
Institute Epidemiological and Clinical research Information Network (ECRIN)
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010390

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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