UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN C000000424
Receipt No. R000000489
Scientific Title Pharmacogenomic study of modified FOLFOX6 (combination chemotherapy of Oxaliplatin with infusional 5-FU/l-Leucovorin) in colorectal cancer
Date of disclosure of the study information 2006/06/03
Last modified on 2008/05/29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Pharmacogenomic study of modified FOLFOX6 (combination chemotherapy of Oxaliplatin with infusional 5-FU/l-Leucovorin) in colorectal cancer
Acronym Pharmacogenomic study of modified FOLFOX6 in colorectal cancer
Scientific Title Pharmacogenomic study of modified FOLFOX6 (combination chemotherapy of Oxaliplatin with infusional 5-FU/l-Leucovorin) in colorectal cancer
Scientific Title:Acronym Pharmacogenomic study of modified FOLFOX6 in colorectal cancer
Region
Japan

Condition
Condition Chemotherapy-naïve stage IV colorectal cancer after palliative operation
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the efficacy and safety of modified FOLFOX6 (5-FU/l-LV+Oxaliplatin)therapy as the first-line adjuvant chemotherapy for stage IV colorectal cancer patients, and identify the potent biomarkers
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Response rate(best tumor shrinkage(rate))
Key secondary outcomes 1.Overall response duration, Complete response duration, Stable duration
2.Progression free survival(PFS)
3.Time to treatment failure(TTF)
4.Overall survival(OS), Median survival time(MST), 1-year survival,2-year survival
5.Adverse events
6.Possible biomarkers
a)Association of genotype of DPYD, TYMS, ERCC1, ERCC2, XRCC1, GSTP1, EGFR, VEGF and TNFRSF1B and expression of DPYD, TYMS, ECGF1 and ERCC1 with phenotype
b)Identification of possible biomarker genes other than DPYD, TYMS, ECGF1, ERCC1, ERCC2, XRCC1, GSTP1, EGFR, VEGF and TNFRSF1B
c)Association of platinum concentration in plasma and ultrafiltrate with neurotoxicity and allergic reaction

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 Intravenous administration of l-Leucovorin 175 mg/body, Oxaliplatin 85 mg/m2 as a 2-hour infusion followed by bolus 5-FU 400 mg/m2 and 46hr infusion 5-FU 2,400 mg/m2 every two weeks
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
75 years-old >=
Gender Male and Female
Key inclusion criteria (1)With pathologically proven colorectal cancer
(2)With Stage IV colorectal cancer after palliative operation
(3)With at least one measurable lesion (RECIST)
(4)With adequate bone marrow, cardiac, respiratory, hepatic, and renal functions. Defined as:
Leucocyte count >=4000 mm3, neutrophil count >=2000 mm3, platelet count >=100,000 mm3, haemoglobin >=9.0 g/dl, AST and ALT ==60 ml/min., BUN level =<25 mg/dl and normal ECG
(5)ECOG performance status =<2
(6)No prior therapy other than the palliative operation
(7)Palliative operation was completed<= one month prior to chemotherapy
(8)With collected tissue samples for pharmacogenomic analysis
(9)Life expectancy estimated >=12 weeks
(10)With written informed consent
Key exclusion criteria (1)Symptomatic infectious disease
(2)Watery diarrhea
(3)Ileus, obstructive bowel disease
(4)Interstitial pneumonia, pulmonary fibrosis
(5)Symptomatic malignant ascites, pleural or pericardial effusion
(6)Peripheral neuropathy >= grade 2 (DEB-NTC)
(7)Ischemic heart disease or arrhythmia required medical care
(8)Myocardiac infarction occurred within 6 months
(9)Liver cirrhosis
(10)Hemorrhage, GI-Select >= grade 3 (NCI-CTC)
(11)Symptomatic psychological disease
(12)Uncontrollable diabetes
(13)Active secondary malignancies
(14)A past history of severe drug allergy
(15)Concomitant therapy with phenytoin or warfarin potassium
(16)Pregnancy or breast feeding
(17)Other severe comorbid condition
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiko Nishiyama
Organization Research Institute for Radiation Biology and Medicine,Hiroshima University
Division name Department of Translational Cancer Research
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8553, Japan
TEL 082-257-5839
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masahiko Nishiyama
Organization Research Institute for Radiation Biology and Medicine,Hiroshima University
Division name Department of Translational Cancer Research
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8553, Japan
TEL 082-257-5839
Homepage URL http://www.hictdo.or.jp/tiken.html
Email yamacho@hiroshima-u.ac.jp

Sponsor
Institute Development Organization for Frontier Medical Therapeutics
Institute
Department

Funding Source
Organization Development Organization for Frontier Medical Therapeutics
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Kitazato Univ.,Saitama Med.Sch., Kansai Rosai Hosp.,Sakai Mun.Hosp.,Suita Mun. Hosp.,Osaka Seamen's Insur. Hosp.,Osaka Med.Ctr.Cancer and Cardiovasc. Dis.,Okayama Univ.,Kobe Univ.,Hiroshima Univ.
Name of secondary funder(s) none

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 HiCTDO protocol #7
Org. issuing International ID_1 Development Organization for Frontier Medical Therapeutics
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2006 Year 06 Month 03 Day

Related information
URL releasing protocol http://www.hictdo.or.jp/tiken.html
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
Date of protocol fixation
2006 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 06 Month 01 Day
Last follow-up date
2010 Year 05 Month 01 Day
Date of closure to data entry
2010 Year 05 Month 01 Day
Date trial data considered complete
2010 Year 05 Month 01 Day
Date analysis concluded
2010 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 05 Month 29 Day
Last modified on
2008 Year 05 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000489

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.