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).

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004171

Enrollment

Registered

2010-09-08

Start date

2010-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon cancer

Interventions

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.

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The inhibition ratio of the hand - foot syndrome of all grade	—

Secondary

Measure	Time frame
- 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))	—

Countries

Japan

Contacts

Public ContactToshinori Ando

Tohoku University Graduate School of Medicine Division of Biological Regulation and Oncology

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026