UMIN-CTR Clinical Trial

Basic information
Public title	Preventive Effect of Goshajinkigan on Peripheral Neurotoxicity of FOLFOX Therapy :A Placebo-controlled Double-blind Randomized Phase III Study
Acronym	Goshajinkigan Effect for oxaliplatin Neurotoxicity Inhibition USing mFOLFOX6 regimen(GENIUS)
Scientific Title	Preventive Effect of Goshajinkigan on Peripheral Neurotoxicity of FOLFOX Therapy :A Placebo-controlled Double-blind Randomized Phase III Study
Scientific Title:Acronym	Goshajinkigan Effect for oxaliplatin Neurotoxicity Inhibition USing mFOLFOX6 regimen(GENIUS)
Region	Japan

Condition
Condition	Colorectal cancer
Classification by specialty	Medicine in general Gastroenterology Hematology and clinical oncology Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate benefit of Kampo-goshajinkigan as a supportive therapy for chemo-induced peripheral neuropathy (CIPN) in postoperative mFOLFOX6 adjuvant chemotherapy for p-Stage III colorectal cancer patient in comparison with placebo (Phase III study).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	TimeToGrade2+ (CTCAE v4.0) Neuropathy; TTN
Key secondary outcomes	L-OHP dose intensity DI safety

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Goshajinkigan 7.5g/day, 12 course + mFOLFOX6 12 course
Interventions/Control_2	Placebo 7.5g/day, 12 course + mFOLFOX6 12 course
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)Written informed consent 2)Patients who is judged by investigator to be able to receive the protocol therapy 3)Patients with histologically proven colorectal cancer and lower edge of tumor located upper than Douglas pouch 4)p-Stage IIIa /IIIb 5)R0 (Curability A) 6)Age; 20<=, <=80 7)ECOG performance status 0-1 8)within 8 weeks from operation 9) Patiens have enough organ function based on blood test 1.WBC>=3,000-<=12,000/mm3, 2.Neurtophils>=1,500/mm3 3. Platelets>=100,000/mm3 4. Hemoglobin>=9.0g/dl 5. Total bilirubin<=2.0mg/dl 6.AST<=100U/L 7.ALT<=100U/L 8. Creatinine<=1.5mg/dl
Key exclusion criteria	1)transfusion, G-CSF etc. within 7days 2)severe allergic reaction 3)peripheral neuropthy 4)Simultaneous or metachronous double cancers 5)Active infectious disease 6)Severe mental disease 7)Grade2+, diarrhea 8)systemic administration of corticosteroids 9)Pregnant or lactating women or women of childbearing potential 10)Severe comorbidity (interstitial peumonitis, lung fibrosis, paralytic ileus, mechanical ileus, uncontrollable diabetes, liver cirosis, chronic hepatitis, career with hepatitis B/C, renal failure, heart failure, uncontrollable hypertension, unstable angina etc) 11)AMI within 6 months 12)History of transplantation 13)Preoperative therapy for CRC 14)History of colostomy 15)Unhealing of post-operative complication 16)Gashajinkigan, or drug for neuropathy 17)Any other cases who are regarded as inadequate for study enrollment by the investigator
Target sample size	310

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoshihiro Kakeji
Organization	Graduate School of Medicine, Kobe University
Division name	Division of Gastrointestinal Surgery, Department of Surgery
Zip code
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, JAPAN
TEL	078-382-5925
Email	kakeji@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Satomi Abe
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Surgery and Science
Zip code
Address	Maidashi 3-1-1, Higashi-ku, Fukuoka
TEL	092-642-5466
Homepage URL
Email	abesato@surg2.med.kyushu-u.ac.jp

Sponsor
Institute	Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare (Japan)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	EPS Co., Ltd. TSUMURA & CO. YAMATO LOGISTICS CO,. LTD.
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

九州大学病院（福岡県）、鳥取大学病院（鳥取県）、埼玉医科大学総合医療センター（埼玉県）、広島大学病院（広島県）、久留米大学医学部附属医療センター（福岡県）、箕面市立病院（大阪府）、獨協医科大学病院（栃木県）、国立病院機構米子医療センター（鳥取県）、横浜市立大学附属市民総合医療センター（神奈川県）、群馬大学医学部附属病院（群馬県）、旭川医科大学病院（北海道）、金沢医科大学病院（石川県）、愛知県がんセンター愛知病院（愛知県）、名古屋大学医学部附属病院（愛知県）、高知大学医学部附属病院（高知県）、関西医科大学病院（大阪府）、浜松医科大学医学部附属病院（静岡県）、京都大学医学部附属病院（京都府）、九州がんセンター（福岡県）、徳島大学病院（徳島県）、久留米大学病院（福岡県）、大阪医科大学附属病院（大阪府）、千葉県がんセンター（千葉県）、岐阜市民病院（岐阜県）、兵庫医科大学病院（兵庫県）、川崎医科大学附属病院（岡山県）、長崎大学病院（長崎県）、鹿児島大学病院（鹿児島県）、琉球大学医学部附属病院（沖縄県）、金沢赤十字病院（石川県）、弘前大学医学部附属病院（青森県）、熊本大学医学部附属病院（熊本県）、大阪市立大学医学部附属病院（大阪府）、日本大学病院（東京都）、岡山大学病院（岡山県）、札幌医科大学附属病院（北海道）、藤田保健衛生大学病院（愛知県）、東北大学病院（宮城県）、愛知県がんセンター中央病院（愛知県）、大阪大学医学部附属病院（大阪府）、青森県立中央病院（青森県）、福井大学医学部附属病院（福井県）、岐阜大学医学部附属病院（岐阜県）、北里大学病院（東京都）、国立病院機構別府医療センター（大分県）、関西労災病院（兵庫県）、日本医科大学附属病院（東京都）

Other administrative information
Date of disclosure of the study information	2010 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results	Int J Clin Oncol. 2015 Jan 28. [Epub ahead of print] PMID:25627820[PubMed - as supplied by publisher] Related citations
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	Terminated
Date of protocol fixation	2010 Year 08 Month 12 Day
Date of IRB
Anticipated trial start date	2010 Year 10 Month 01 Day
Last follow-up date	2013 Year 09 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 09 Month 28 Day
Last modified on	2015 Year 02 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005082

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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