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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005899
Receipt No. R000006973
Scientific Title Chinese medicine in postoperative adjuvant chemotherapy (Capecitabine therapy) for colorectal cancer: Examination of prevention of hand-foot syndrome by the prophylactic administration of Eppikajutsutou (clinical phase II study)
Date of disclosure of the study information 2011/07/01
Last modified on 2016/01/20

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Basic information
Public title Chinese medicine in postoperative adjuvant chemotherapy (Capecitabine therapy) for colorectal cancer: Examination of prevention of hand-foot syndrome by the prophylactic administration of Eppikajutsutou (clinical phase II study)
Acronym Examination of prevention of hand-foot syndrome in Capecitabine therapy by the prophylactic administration of Eppikajutsutou
Scientific Title Chinese medicine in postoperative adjuvant chemotherapy (Capecitabine therapy) for colorectal cancer: Examination of prevention of hand-foot syndrome by the prophylactic administration of Eppikajutsutou (clinical phase II study)
Scientific Title:Acronym Examination of prevention of hand-foot syndrome in Capecitabine therapy by the prophylactic administration of Eppikajutsutou
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the hand-foot syndrome controlling effect by the prophylactic administration of Eppikajutsutou for the patient of postoperative adjuvant Capecitabine therapy (B method) by randomized controlled study with vitamin B6
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Incidence rate of hand-foot syndrome of Grade2 or more
Key secondary outcomes 1) Capecitabine therapy completion rate
2) Hand-and-foot syndrome (Palmar-plantar erythrodysesthesia syndrome) incidence ratio (each course Grade)
3) Time until hand-and-foot syndrome of Grade2 or more appearing
4) Capecitabine interruption (interruption frequency and total dosage/schedule dosage)5) Incidence ratios of an adverse event other than hand-and-foot syndrome (frequency and level of adverse event

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
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 Capecitabine + Eppikajutsutou group
One course of Capecitabine: Daily oral administration of Capecitabine (Xeloda) dose according to the body surface area twice a day for 14 days within 30 minutes after the breakfast and the supper, and a rest for seven days afterwards. Total 8 courses are performed.
Eppikajutsutou: Daily oral administration during Capecitabine therapy
Its dose is 7.5g divided in three times/day, before a meal or inter cibos.
Interventions/Control_2 Capecitabine + Vitamin B6 group
One course of Capecitabine: It is the same as intervention 1.
Vitamin B6: Daily oral administration during Capecitabine therapy
Its dose is 60mg divided in three times/day, after a meal.
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
20 years-old >=
Gender Male and Female
Key inclusion criteria Capecitabine therapy patient after resection of colorectal cancer
1)histologically proven colorectal carcinoma and the clinical stage3
2)The radical cure lymphnode dissection (D2 or D3) is done.
3)tumor located in the cecum, ascending colon, transverse colon, descending colon, sigmoid colon, rectosigmoid colon, or upper rectum, and the distal edge of tumor is above the peritoneal reflection.
4)age 20< =and >=80 years
5)Performance Status(ECOG) is 0-1.
6)An advanced trouble is not provided as the main internal organs function (Fill everything the following with the inspection within 14 days before it registers).
(1)White blood cell count >=3,000/mm3 and <=12,000/ mm3
(2)Platelet number >=100,000/ mm3
(3) Hemoglobin >= 9.0 g/dl
(4) AST(GOT) ALT(GPT) <= facilities standard value upper bound *2.5
(5)Serum total bilirubin <= 1.5 mg/dl(6)Serum creatinine <= 1.5 mg/dl
7)Provided written informed consent
Key exclusion criteria 1) severe hypersensitivity
2) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
3) The infectious disease of briskness
4) severe mental disease
5) continuous systemic steroid therapy
6) pregnant or lactating women
7) severe concomitance disease (Interstitial pneumonia, Lung fibrosis, Intestinal paralysis, Intestinal obstruction, uncontrolled Diabetes, Liver cirrhosis or Chronic hepatitis (B type and C type), etc.)
8) organ transplant patient
9) Neoadjuvant therapy (chemotherapy, radiation therapy, and hormone treatment, etc.)
10) colostomy (temporarily contained)
11) Postoperative complications do not recover.
12) remarkable perspiration tendency
13) cardiac dysfunction or cardiac infarction within six months
14) severe hypertension
15) severe renal dysfunction
16) Dysuria
17) Hyperthyroidism
18) improper as patient of clinical trial
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Itaru Endo, MD. PhD.
Organization Yokohama City University Hospital
Division name Department of Gastroenterological Surgery
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
TEL 045-787-2800
Email endoit@med.yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuyoshi Ota
Organization Yokohama City University Medical Center
Division name Gastroenterological center
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Homepage URL
Email m_ota@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Medical Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Yokohama Clinical Oncolgy Group (YCOG)
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 横浜市立大学附属市民総合医療センター(神奈川県)
横浜市立大学附属病院(神奈川県)
横浜市立みなと赤十字病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2011 Year 07 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
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 Completed
Date of protocol fixation
2011 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2011 Year 07 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
2011 Year 07 Month 01 Day
Last modified on
2016 Year 01 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006973

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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