UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004282
Receipt number R000005082
Scientific Title Preventive Effect of Goshajinkigan on Peripheral Neurotoxicity of FOLFOX Therapy :A Placebo-controlled Double-blind Randomized Phase III Study
Date of disclosure of the study information 2010/10/01
Last modified on 2015/02/02 22:08:42

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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