UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006905 |
|---|---|
| Receipt number | R000008162 |
| Scientific Title | Pharmacogenomic study on colorectal cancer chemotherapy - modified FOLFOX6- (Oxaliplatin with infusional 5-FU/l-Leucovorin) and FOLFIRI (irinotecan with infusional 5-FU/l-Leucovorin)-based regimen- |
| Date of disclosure of the study information | 2011/12/19 |
| Last modified on | 2019/06/25 16:18:15 |
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Basic information
Public title
Pharmacogenomic study on colorectal cancer chemotherapy - modified FOLFOX6- (Oxaliplatin with infusional 5-FU/l-Leucovorin) and
FOLFIRI (irinotecan with infusional 5-FU/l-Leucovorin)-based regimen-
Acronym
Pharmacogenomic study on colorectal cancer chemotherapy
Scientific Title
Pharmacogenomic study on colorectal cancer chemotherapy - modified FOLFOX6- (Oxaliplatin with infusional 5-FU/l-Leucovorin) and
FOLFIRI (irinotecan with infusional 5-FU/l-Leucovorin)-based regimen-
Scientific Title:Acronym
Pharmacogenomic study on colorectal cancer chemotherapy
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To assess the efficacy and safety of modified FOLFOX6 and FOLFIRI with or without Bevacizmab for Stage IV unresectable colorectal cancer: Multicentric phase II randomized study. Predictive formulaes for CPT11 and mFOLFOX6 that have been developed for tailored-therapy will be validated for their possibility of application. Novel biomarker candidates will also be explored for these therapies.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate (RECISTv1.1)
Key secondary outcomes
Evaluation of efficacy and safety.
(1) Overall response duration, Complete response duration, Stable duration
(2)Progression free survival
(3)Time to treatment failure
(4)Survival: Overall survival, OS, Median survival Time, 1-year survival, 2-year survival
(5) Toxicity profiles, frequency, grade, timing
Feasibility of novel and known biomarkers
(1)Feasibility of novel biomarkers for prediction of response
(2) Feasiblity of known biomarkers for prediction of efficacy or adverse effects
(3) Establishment of new predictive markers,
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
mFOLFOX6 (-BEV):
On Day1, iv infusion of 85 mg/m2 of l-OHP and 175 mg/m2 of L-LV for 2hrs, followed by bolus infusion of 400 mg/m2 5-FU. Then, continuous infusion of 2400 mg/m2 5-FU for 46 hrs. 1 course, 2 weeks. Continue the courses till the discontinuance criteria.
Interventions/Control_2
mFOLFOX6 (+BEV):
The first treatment after the surgery is subject to the mFOLFOX6 (-BEV) regimen. From the 2nd cycle, first infusion of 5 mg/kg BEV. Then follow the mFOLFOX6 (-BEV) regimen. 1 course, 2 weeks. Continue the courses till the discontinuance criteria.
Interventions/Control_3
mFOLFIRI(-BEV):
On Day1, iv infusion of 150 mg/m2 of CPT-11 and 175 mg/m2 of L-LV for 2 hrs, followed by bolus infusion of 400 mg/m2 5-FU. Then, continuous infusion of 2400 mg/m2 5-FU for 46 hrs. 1 course, 2 weeks. Continue the courses till the discontinuance criteria.
Interventions/Control_4
mFOLFIRI (+BEV):
The first treatment after the surgery is subject to the FOLFIRI (-BEV) regimen. From the 2nd cycle, first infusion of 5 mg/kg BEV. Then follow the FOLFIRI (-BEV) regimen. 1 course, 2 weeks. Continue the courses till the discontinuance criteria.
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) Stage IV unresectable case.
3) The patient must have measurable disease (RECIST)
4) Patient must have appropriate organ function (bone marrow, liver, kidney, cardiac, etc.) and the laboratory value within 7 days before the protocol treatment must be
WBC 4,000/mm3 or more
ANC 2,000/mm3 or more
Platelet 100,000/mm3 or more
Hemoglobin 9.0g/dl or more
AST, ALT x2 institutional ULN or less
(For the liver metastatic cases, x3 institutional ULN or less)
Serum Total Bilirubin 1.5 mg/dL or less
Serum Creatinine 1.5 mg/dL or less
Creatinine clearance 60 ml/min or more
BUN 25mg/dl or less
ECG Normal
5) ECOG Performance Status 0-2
6) Any therapy should not have been given for the current disease.
7) Protocol treatment must be started within 6 weeks after surgery.
8) Collected tissue sample must be enough for genomic analysis.
9) Life expectancy must be 12 weeks or more at the time of registration.
10) Age 20 years or older
11) Written informed consent must be obtained for the study including blood or tissue sampling.
Key exclusion criteria
1) Patients with obvious infectious disease.
2) Patients with watery diarrhea.
3) Patients with intestinal paralysis, obstruction, or subobstruction of bowel (At the time of registration)
4) Patients with interstitial pneumonia or pulmonary fibrosis
5) Patients with considerable cancerous body cavity fluid.
6) Patients with severe paresthesia of functional disorder or dysesthesia
7) Patients with peripheral (sensory or motor) neuropathy Grade 2 or greater (CTCAEv4.0).
8) Patients with treatment-required ischemic heart disease or cardiac disease such as arrhythmia (left ventricular hypertrophy associated with hypertension, mild left ventricular over-loading, or mild right bundle branch block etc. are acceptable for registration)
9) Patients with history of myocardial infarction within 6 months
10) Patients with liver cirrhosis
11) Patients with active bleeding at bowel with necessity for frequent transfusion
12) Patients with clinically serious psycho-neurological disease required for continuation therapy using psychotropic drug
13) Patients with uncontrollable diabetes
14) Patients with active double cancer
15) Patients with history of severe hypersensitivitie for other drugs
16) Patients required for continuous administration of phenytoin
17) Patients with obvious intraperitoneal inflammation
18) Patients with uncured surgical wound of serious operation
19) Patients with congenital hemorrhagic diathesis
20) Patients with administration of anticoagulant such as warfarin potassium
21) Patients with history of thromboembolism
22) Patients who are pregnant or breast feeding or possibility of pregnancy
23) Patients with severe comorbidity who are difficult for continuation of the protocol treatment
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Nishiyama |
Organization
Saitama Medical University
Division name
Frontier Medical Development Center
Zip code
Address
1397-1 Yamane, Hidaka, Saitama 350-1298, Japan
TEL
042-984-4668
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiko Nishiyama |
Organization
Saitama Medical University
Division name
Frontier Medical Development Center
Zip code
Address
1397-1 Yamane, Hidaka, Saitama 350-1298, Japan
TEL
042-984-4668
Homepage URL
yamacho@saitama-med.ac.jp
Sponsor or person
Institute
Personalized Medicine Study Group for Cancer
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
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
DOFMET Protocol #5
Org. issuing International ID_1
Development Organization for Frontier Medical Therapeutics
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
九州大学大学院医学研究院・消化器総合外科学 （福岡県）、
熊本大学大学院生命科学研究部・消化器外科学 （熊本県）、
鹿児島大学大学院医歯学総合研究科・腫瘍制御学・消化器外科学 （鹿児島県）、
ICSG (Individualized Chemotherapy Study Group)
関西労災病院・外科 （兵庫県）
市立堺病院・外科 （大阪府）
市立吹田市民病院・外科・消化器内科 （大阪府）
大阪府立成人病センター・消化器外科，臨床腫瘍科 （大阪府）
兵庫医科大学・下部消化器外科 （兵庫県）
医療法人薫風会 佐野病院 （兵庫県）、
岐阜大学大学院医学研究科・腫瘍外科学 （岐阜県）、
北里大学医学部・外科学 （神奈川県）、
帝京大学ちば総合医療センター・外科 （千葉県）、
群馬大学大学院医学研究科病態総合外科学 （群馬県）、
埼玉医科大学総合医療センター・消化管・一般外科 （埼玉県）、
岩手医科大学・外科学 （岩手県）、
埼玉医科大学先端医療開発センター （埼玉県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 19 | 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 | 09 | Month | 29 | Day |
Date of IRB
| 2011 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 01 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 01 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 01 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 19 | Day |
Last modified on
| 2019 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008162
