UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007117 |
|---|---|
| Receipt number | R000008372 |
| Scientific Title | Gunma study - Oxaliplatin-based chemotherapy and Avastin following Irinotecan-based chemotherapy with Erbitux in metastatic colorectal cancer |
| Date of disclosure of the study information | 2012/01/23 |
| Last modified on | 2020/09/01 14:50:44 |
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Basic information
Public title
Gunma study - Oxaliplatin-based chemotherapy and Avastin following Irinotecan-based chemotherapy with Erbitux in metastatic colorectal cancer
Acronym
GARNET TRIAL
Scientific Title
Gunma study - Oxaliplatin-based chemotherapy and Avastin following Irinotecan-based chemotherapy with Erbitux in metastatic colorectal cancer
Scientific Title:Acronym
GARNET 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 FOLFIRI+Cetuximab(q2w) as first line and FOLFOX or XELOX +Bevacizumab as second line in metastatic colorectal cancer with EGFR-detectable and KRAS wild type
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Total Progression free survival (PFS1+PFS2):
PFS during first-line (PFS1) and PFS during second-line (PFS2)
Key secondary outcomes
Progression free survival during first-line (PFS1)
Progression free survival during second-line (PFS2)
Response rate during first-line (RR1)
Response rate during second-line (RR2)
Tumor shrinkage rate at 8 weeks in first-line
Overall survival (OS)
Survival beyond progression (SBP)
Safety
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
first line chemotherpy
FOLFIRI+Cetuximab
(Cetuximab 500mg/m2/bi-week
CPT-11 150mg/m2/bi-week
l-LV 200mg/m2/bi-week
5-FU/bolus 400mg/m2/bi-week
5-FU/infusional 2,400mg/m2/bi-week (day 1-3))
FOLFIRI+Cetuximab
second line chemotherapy (1)
mFOLFOX6+Bevacizumab
(Bevacizumab 5mg/kg/bi-week
L-OHP 85mg/m2/bi-week
l-LV 200mg/m2/bi-week
5-FU/bolus 400mg/m2/bi-week
5-FU/infusional 2,400mg/m2/bi-week (day 1-3))
second line chemotherapy (2)
XELOX+Bevacizumab
(Bevacizumab 7.5mg/kg/tri-week
L-OHP 130mg/m2/tri-week
Capecitabine 2000mg/m2/day/2 (day 1-15))
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with histologically proven colorectal cancer
2) Metastatic colorectal cancer with EGFR expressed
3) Metastatic colorectal cancer with KRAS wild-type
4) No prior chemotherapy (Patients who recieved treatment including oxaliplatin or fluoropyrimidine type anti-cancer drugs before 24 weeks are eligibled)
5) 20 years-old<=
6) PS:0-1(EGOG performance status score)
7) Presence of measurable lesion (RECIST Ver.1.1)
8) Patients who are tolerant to oral administration
9) Patients have enough organ function for study treatment
i leucocytes>=3,000/mm3,neutrophils>=1,500/mm3
ii platelets>=100,000/mm3
iii hemoglobin>=9.0g/dl
iv AST(GOT),ALT(GPT),ALP<=twice as upper limit of normal (ULN)(5 timesif showing liver disease)
v total blirubin<=half time as upper limit of normal(ULN)
vi creatinine<=half time as upper limit of normal(ULN)
10) Life expectancy of more than 3 months
11) Written informed consent
Key exclusion criteria
1) Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease-free interval
2) Symptomatic brain metastases
3) Severe myelosuppression
4) Watery diarrhea
5) Severe infectious disease
6) Interstitial lung disease or pulmonary fibrosis
7) Comorbidity or history of severe heart failure
8) Sensory alteration or paresthesia interfering with function
9) Need to drain malignant coelomic fluid
10) Severe comorbidity
11) Paralytic or mechanical bowel obstruction
12) Jaundice
13) Patient taking Atazanavir sulphate
14) Men/women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test
15) History of severe allergy
16) History of allergy for Cetuximab, Bevacizumab, fluoropyrimidine, irinotecan, oxaliplatin and other platinating agent
17) Prior treatment of Cetuximab, Bevacizumab, fluoropyrimidine, irinotecan and oxaliplatin
Any other cases who are regarded as inadequate for study enrollment by investigators
Target sample size
53
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Kuwano |
Organization
Gunma University Graduate school of Medicine
Division name
Department of General surgical science
Zip code
Address
3-39-22 syouwamachi, Maebashi, Gunma, Japan, 371-8511
TEL
027-220-8224
hkuwano@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Kuwano |
Organization
Gunma University Graduate school of Medicine
Division name
Department of General surgical science
Zip code
Address
3-39-22 syouwamachi, Maebashi, Gunma, Japan, 371-8511
TEL
027-220-8225
Homepage URL
hkuwano@med.gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Graduate school of Medicine Department of General surgical science clinical study group
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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 | 01 | Month | 23 | 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
Completed
Date of protocol fixation
| 2011 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2011 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 10 | 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
| 2012 | Year | 01 | Month | 23 | Day |
Last modified on
| 2020 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008372
