UMIN-CTR Clinical Trial

Basic information
Public title	A study on combinational effect of Krestin to the peripheral neuropathy by the FOLFOX treatment as adjuvant chemotherapy for Stage III colon cancer.
Acronym	A study on combinational effect of Krestin to the peripheral neuropathy by the FOLFOX treatment as adjuvant chemotherapy for Stage III colon cancer.
Scientific Title	A study on combinational effect of Krestin to the peripheral neuropathy by the FOLFOX treatment as adjuvant chemotherapy for Stage III colon cancer.
Scientific Title:Acronym	A study on combinational effect of Krestin to the peripheral neuropathy by the FOLFOX treatment as adjuvant chemotherapy for Stage III colon cancer.
Region	Japan

Condition
Condition	Colon cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	In this randomized controlled study, patients with curatively resected Stage III colon cancer are assigned to postoperative adjuvant therapy with FOLFOX or FOLFOX plus Krestin to evaluate the efficacy of immunochemotherapy combined with Krestin. Endpoints are peripheral neuropathy or myelosuppresion such as neutropenia.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Frequency of peripheral neuropathy
Key secondary outcomes	Frequency of neutropenia, other adverse events, medication adherence, QOL

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	FOLFOX (1) FOLFOX4 Patients are registered and assigned within 6weeks after surgery. Levofolinate and Oxaliplatin (L-OHP) are given intravenously for 2 hours. Then, Fluorouracil (5-FU) is given as a continuous intravenous infusion for 22 hours after infusion (or injection) of 5-FU. And then, levofolinate is given intravenously for 2 hours, 5-FU is given as a continuous intravenous infusion for 22 hours after infusion (or injection) of 5-FU. 1 course takes 2 weeks. Treatment is repeated 12 courses (for 24 weeks). (2) mFOLFOX6 Patients are registered and assigned within 6weeks after surgery. Levofolinate and L-OHP are given intravenously for 2 hours. Then, 5-FU is given as a continuous intravenous infusion for 46 hours after infusion (or injection) of 5-FU. 1 course takes 2 weeks. Treatment is repeated 12 courses (for 24 weeks).
Interventions/Control_2	FOLFOX/Krestin Krestin is given orally at a fixed dose of 3g/day in three divided doses (morning, daytime, evening) for 24 weeks from the time of a FOLFOX treatment start.
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 proven, Stage IIIa, IIIb, primary Colon adenocarcinoma (including RS) (Japanese Classification of Colorectal cancer 7th Ehition). 2. R0. 3. No preoperative cancer treatment, such as radiotherapy, chemotherapy and immunotherapy. 4. Age between 20 and 80 years. 5. ECOG performance status of 0-1. 6. Organ functions (clinical test value): within 2 weeks before enrollment. White blood cell count: over 4000/mm3 and <12000/mm3 Neutrophil count (ANC): over 2000/mm3 Blood platelet count: over 100,000 /mm3 Hemoglobin: over 9.0g/dl Serum total bilirubin: <1.5mg/dl Serum AST and ALT: <100 IU/L Serum creatinine: below 1.5mg/dL Normal ECG 7. Patients who can take orally. 8. Written informed consent.
Key exclusion criteria	1. Patients who need continuing use of warfarin potassium and phenytoin. 2. A medical history of allergy (over grade 3) to any drug. 3. Patients with severe complication (such as ileus, interstitial lung disease, lung fibrosis, diabetes that is difficult to control, heart failure, renal failure, liver failure). 4. Women who are pregnant or hope to become pregnant. 5. No birth-control. 6. HIV positive. 7. Patients judged inappropriate for the study by their physicians. Patients with intraepithelial carcinoma, adenoma cancer, synchronous or metachronous cancers are not exclusion criterion.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masahiko Shibata
Organization	Fukushima Medical University
Division name	Tumor Host Bioscience
Zip code
Address	1, Hikarigaoka, Fukushima city, 960-1295 Japan
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name
Organization	Fukushima Medical University
Division name	Tumor Host Bioscience
Zip code
Address	1, Hikarigaoka, Fukushima city, 960-1295 Japan
TEL
Homepage URL
Email

Sponsor
Institute	Tumor Host Bioscience, Fukushima Medical University
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 10 Month 08 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 08 Month 26 Day
Date of IRB
Anticipated trial start date	2010 Year 10 Month 01 Day
Last follow-up date
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 07 Day
Last modified on	2012 Year 10 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005187

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.