Unique ID issued by UMIN | UMIN000004282 |
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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 |
Preventive Effect of Goshajinkigan on Peripheral Neurotoxicity of FOLFOX Therapy :A Placebo-controlled Double-blind Randomized Phase III Study
Goshajinkigan Effect for oxaliplatin Neurotoxicity Inhibition USing mFOLFOX6 regimen(GENIUS)
Preventive Effect of Goshajinkigan on Peripheral Neurotoxicity of FOLFOX Therapy :A Placebo-controlled Double-blind Randomized Phase III Study
Goshajinkigan Effect for oxaliplatin Neurotoxicity Inhibition USing mFOLFOX6 regimen(GENIUS)
Japan |
Colorectal cancer
Medicine in general | Gastroenterology | Hematology and clinical oncology |
Surgery in general | Gastrointestinal surgery |
Malignancy
NO
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).
Efficacy
Confirmatory
Pragmatic
Phase III
TimeToGrade2+ (CTCAE v4.0) Neuropathy; TTN
L-OHP dose intensity DI
safety
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine |
Goshajinkigan 7.5g/day, 12 course + mFOLFOX6 12 course
Placebo 7.5g/day, 12 course + mFOLFOX6 12 course
20 | years-old | <= |
80 | years-old | >= |
Male and Female
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
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
310
1st name | |
Middle name | |
Last name | Yoshihiro Kakeji |
Graduate School of Medicine, Kobe University
Division of Gastrointestinal Surgery, Department of Surgery
7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, JAPAN
078-382-5925
kakeji@med.kobe-u.ac.jp
1st name | |
Middle name | |
Last name | Satomi Abe |
Graduate School of Medical Sciences, Kyushu University
Department of Surgery and Science
Maidashi 3-1-1, Higashi-ku, Fukuoka
092-642-5466
abesato@surg2.med.kyushu-u.ac.jp
Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University
Ministry of Health, Labour and Welfare (Japan)
Japan
EPS Co., Ltd.
TSUMURA & CO.
YAMATO LOGISTICS CO,. LTD.
NO
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)
2010 | Year | 10 | Month | 01 | Day |
Published
Int J Clin Oncol. 2015 Jan 28. [Epub ahead of print]
PMID:25627820[PubMed - as supplied by publisher]
Related citations
Terminated
2010 | Year | 08 | Month | 12 | Day |
2010 | Year | 10 | Month | 01 | Day |
2013 | Year | 09 | Month | 01 | Day |
2010 | Year | 09 | Month | 28 | Day |
2015 | Year | 02 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005082
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