UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of adjuvant chemotherapy of OPTIMOX therapy (intermittent FOLFOX regimen) for Stage III colon cancer (including Rectosigmoid cancer).
Acronym	Triple 4 study
Scientific Title	Phase II study of adjuvant chemotherapy of OPTIMOX therapy (intermittent FOLFOX regimen) for Stage III colon cancer (including Rectosigmoid cancer).
Scientific Title:Acronym	Triple 4 study
Region	Japan

Condition
Condition	Colon cancer (including Rectosigmoid cancer)
Classification by specialty	Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The primary end piont of this study is to assess the efficacy and safety of OPTIMOX therapy (intermittent FOLFOX regimen) as adjuvant chemotherapy for Stage III colon cancer including Rectosigmoid cancer.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	The incidence of oxaliplatin induced neuropathy.
Key secondary outcomes	The incidence of all adverse events (Excluding neuropathy). Disease free survival (DFS) Overall survival (OS)

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	Adjuvant chemotherapy Oxaliplatin 85mg/m2/bi-week(day1) l-LV 200 mg/m2/bi-week(day1) 5-FU/bolus 400mg/m2/bi-week bolus(day1) 5-FU/infusional 2400mg/m2/bi-week(day1-3)
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Histologically confirmed Colorectal adenocarcinoma and histological Stage III Colon cancer (including Rectosigmoid cancer). 2.Curative resection with D2 or more extensive lymph node dissection. 3.Resection of histological curability A was performed. 4.Age: 20-80 years old. 5.Performance status (ECOG):0-2 6.No prior chemotherapy and radiotherapy and immunotherapy. 7.Adequate organ function. * WBC:3,000/mm3-12,000/mm3 * Neutrophil count <=1500/mm3. * Platelet count<=;100,000/mm3. Liver function tests * AST (GOT) and ALT (GPT)>=;2.5*ULN. * Total bilirubin>=;2.5*ULN. Renal function test * Serum creatinine>=;1.25*ULN. 8.Chemotherapy will be started within 8 weeks from operation. 9.Written informed consent.
Key exclusion criteria	1.Pregnant or nursing 2.Administering antithrobotic drug within 14 days 3.Medical history of allergy or hypersensitivity reactions. 4.Peripheral neuropathy (CTC AE v3.0 <= Grade1) 5.Active infection 6.Serious complications (renal failure or hepatic failure or heart failure) 7.Interstitial pnumonitis, pulmonary fibrosis or high-grade pulmonary emphysema. 8.Treated heart disease within 12 months 9.History of mental disturbances or cerebrovascular attack. 10.Watery diarrhea. 11.History of other colorectal cancer (including; sarcoma, carcinoid, lymphoma etc). 12.History of cancer (disease free interval was less than 10 years) 13.Double cancer. 14.Other conditions not suitable for this study
Target sample size	85

Research contact person
Name of lead principal investigator	1st name Middle name Last name Iwao Sasaki
Organization	Tohoku University Graduate School of Medicine
Division name	Division of Biological-regulation and Oncology
Zip code
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Toshinori Ando, Koh Miura
Organization	Tohoku University Graduate School of Medicine
Division name	Division of Biological-regulation and Oncology
Zip code
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
TEL	022-217-7205
Homepage URL
Email

Sponsor
Institute	Tohoku University Graduate School of Medicine
Institute
Department

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
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 06 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	Open public recruiting
Date of protocol fixation	2010 Year 01 Month 26 Day
Date of IRB
Anticipated trial start date	2010 Year 02 Month 01 Day
Last follow-up date	2015 Year 12 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 05 Month 28 Day
Last modified on	2010 Year 05 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004328

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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