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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004171
Receipt No. R000005009
Scientific Title Phase II trial of Vitamin B6 for the HFS related to Capecitabine in adjuvant setting ( in Stage III colon cancer).
Date of disclosure of the study information 2010/09/08
Last modified on 2010/09/08

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Basic information
Public title Phase II trial of Vitamin B6 for the HFS related to Capecitabine in adjuvant setting ( in Stage III colon cancer).
Acronym Phase II trial of Vitamin B6 for the HFS related to Capecitabine in adjuvant setting ( in Stage III colon cancer).
Scientific Title Phase II trial of Vitamin B6 for the HFS related to Capecitabine in adjuvant setting ( in Stage III colon cancer).
Scientific Title:Acronym Phase II trial of Vitamin B6 for the HFS related to Capecitabine in adjuvant setting ( in 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 To evaluate the safety profile of Vitamin B6 for the HFS related to Capecitabine in adjuvant setting ( in Stage III colon cancer ).
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes The inhibition ratio of the hand - foot syndrome of all grade
Key secondary outcomes - Disease free survival
- Relapse free survival
- A treatment successful execution rate
- Safety (The incidence of the grade2/3/4 adverse event (include the side effect of B6))

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 As adjuvant chemotherapy
Capecitabine 2,500mg/m2/day for 14 days to be repeated every 3 weeks 8 times.
Hydrochloric acid pyridoxine
180mg/day until PD or withdrawal.
Interventions/Control_2
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 proved colorectal carcinoma
2. Stage IIIA/IIIB (Japanese classification) colorectal carcinoma
3. Needs >=D2 lymph node dissection
4. Needs Pathological A curability
5. Age 20-79 years
6. ECOG performance status 0-1
7. Needs adequate organ function
8. Able to start this protocol treatment within 8 weeks after surgery
9. Able to have foods and drugs
10. No prior chemotherapy or radiotherapy
11. Written informed consent
Key exclusion criteria 1. Multiple cancer patient (within 5 years)
2. Severe infection or serious complications, such as hypoalimentation
3. Serious postoperative complications are not restored by registration
4. Have following complications
I) Uncontrollable diabetes
II) Uncontrollable hypertension
III) The cirrhosis of the liver
5. Judged by the investigator to be unfit in the study for abnormality of the electrocardiogram, abnormal cardiac function having a history of serious heart trouble
6. Upper part digestive organs disorder or absorption disorder
7. Pregnancy, lactation woman, or woman with suspected pregnancy
8. Severe mental disease
9. Any subject judged by the investigator to be unfit for any reason to participate in the study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Iwao Sasaki
Organization Tohoku University Graduate School of Medicine
Division name Division of Biological Regulation and Oncology
Zip code
Address 1-1 Seiryou-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshinori Ando
Organization Tohoku University Graduate School of Medicine
Division name Division of Biological Regulation and Oncology
Zip code
Address 1-1 Seiryou-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
TEL
Homepage URL
Email

Sponsor
Institute Tohoku University Graduate School of Medicine
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 09 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 05 Month 07 Day
Date of IRB
Anticipated trial start date
2010 Year 09 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 09 Month 08 Day
Last modified on
2010 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005009

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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