UMIN-CTR Clinical Trial

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
Email	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
Email	hkuwano@med.gunma-u.ac.jp

Sponsor
Institute	Gunma University Graduate school of Medicine Department of General surgical science clinical study group
Institute
Department

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
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 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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008372