Unique ID issued by UMIN | UMIN000004171 |
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Receipt number | 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 09:24:56 |
Phase II trial of Vitamin B6 for the HFS related to Capecitabine in adjuvant setting ( in Stage III colon cancer).
Phase II trial of Vitamin B6 for the HFS related to Capecitabine in adjuvant setting ( in Stage III colon cancer).
Phase II trial of Vitamin B6 for the HFS related to Capecitabine in adjuvant setting ( in Stage III colon cancer).
Phase II trial of Vitamin B6 for the HFS related to Capecitabine in adjuvant setting ( in Stage III colon cancer).
Japan |
Colon cancer
Gastrointestinal surgery |
Malignancy
NO
To evaluate the safety profile of Vitamin B6 for the HFS related to Capecitabine in adjuvant setting ( in Stage III colon cancer ).
Safety
Phase II
The inhibition ratio of the hand - foot syndrome of all grade
- 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))
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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.
20 | years-old | <= |
80 | years-old | > |
Male and Female
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
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
30
1st name | |
Middle name | |
Last name | Iwao Sasaki |
Tohoku University Graduate School of Medicine
Division of Biological Regulation and Oncology
1-1 Seiryou-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
1st name | |
Middle name | |
Last name | Toshinori Ando |
Tohoku University Graduate School of Medicine
Division of Biological Regulation and Oncology
1-1 Seiryou-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
Tohoku University Graduate School of Medicine
None
Self funding
NO
2010 | Year | 09 | Month | 08 | Day |
Unpublished
Open public recruiting
2010 | Year | 05 | Month | 07 | Day |
2010 | Year | 09 | Month | 01 | Day |
2010 | Year | 09 | Month | 08 | Day |
2010 | Year | 09 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005009
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