UMIN-CTR Clinical Trial

Basic information
Public title	A tolerability study in Japan of Oxaliplatin, fluorouracil, and l-leucovorin for patients with stage II/III colon cancer
Acronym	A tolerability study in Japan of OxaliplatIN, fluorouracil, and l-leucovorin for patients with stage II/III colon cancer(JFMC41-1001-C2: JOIN Trial)
Scientific Title	A tolerability study in Japan of Oxaliplatin, fluorouracil, and l-leucovorin for patients with stage II/III colon cancer
Scientific Title:Acronym	A tolerability study in Japan of OxaliplatIN, fluorouracil, and l-leucovorin for patients with stage II/III colon cancer(JFMC41-1001-C2: JOIN Trial)
Region	Japan

Condition
Condition	StageII/III colon 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 confirm tolerability Oxaliplatin, fluorouracil, and l-leucovorin for Japanese patients with stage II/III colon cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	The frequency of allergies, anaphylaxis, and peripheral sensory neuropathy lasting for 8 days (Grade 3 or 4).
Key secondary outcomes	(1) Disease-free survival. (2) Relapse-free survival. (3) Time to treatment failure. (4) Overall survival. (5) Adverse events. (6) Peripheral neuropathy. (7) Completion rate. (8) Relative dose intensity. (9) Relationship between lymph node metastasis and prognosis. (10) Exploration of predictors of the prognosis and adverse events (Additional study).

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 Gene
Interventions/Control_1	L-OHP85mg/m2,l-LV200mg/m2, 5FU400mg/m2(bolus),and 5FU2400mg/m2(infusion)
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Stage II/Stage III, histologically confirmed colon cancer. 2) Curability A. 3) Chemotherapy starting within 7 weeks after resection and 2 weeks after registration. 4) Age of 20 years or older. 5) Performance status of 0-2. 6) No prior chemotherapy, immunotherapy, or radiation. 7) Adequate organ function: i) neutrophil count >1,500 /mm3, ii) platelet count >=100,000/mm3, iii) serum creatinine <=1.25 times the ULN, iv) total bilirubin <2 times the ULN, v) AST, ALT <2 times the ULN, and vi) CEA <10 ng/mL. 8) Pregnancy test: (-). 9) Women who will not become pregnant. 10) Written informed consent.
Key exclusion criteria	1) Women who are pregnant or breast-feeding. 2) Women who are planning to become pregnant. 3) Appendix cancer. 4) Patients with a history of malignancy. 5) Participating in another clinical trial within 30 days. 6) Peripheral sensory neuropathy >= Grade 1. 7) Insulin-treated diabetic patients. 8) Uncontrolled congestive heart failure, angina pectoris, hypertension, and arrhythmia. 9) Patients with a history of significant neurological or mental illness. 10) Active infectious disease. 11) Other patients who are unfit for the study as determined by the attending physician.
Target sample size	800

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Takayuki Yoshino
Organization	National Cancer Center Hospital East
Division name	Endoscopy & Gastrointestinal Oncology
Zip code
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577 Japan
TEL
Email

Public contact
1st name of contact person	1st name Middle name Last name Japanese Foundation for Multidisciplinary Treatment of Cancer
Organization	Japanese Foundation for Multidisciplinary Treatment of Cancer
Division name	Office
Zip code
Address	1-28-6 kameido, koutou-ku, Tokyo, 136-0071, Japan
TEL	03-5627-7594
Homepage URL	http://www.jfmc.or.jp/
Email	jfmc-dc@jfmc.or.jp

Sponsor
Institute	Japanese Foundation for Multidisciplinary Treatment of Cancer
Institute
Department

Funding Source
Organization	Yakult Honsha Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
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	2010 Year 11 Month 01 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	2010 Year 10 Month 04 Day
Date of IRB
Anticipated trial start date	2010 Year 11 Month 01 Day
Last follow-up date	2015 Year 03 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	2010 Year 10 Month 26 Day
Last modified on	2015 Year 10 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005318

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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