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Phase II trial as new adjuvant chemotherapy regimen for capecitabine in stage II and III colorectal cancer.

Phase II trial as new adjuvant chemotherapy regimen for capecitabine in stage II and III colorectal cancer. - Phase II trial as new adjuvant chemotherapy regimen for capecitabine

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012813
Enrollment
25
Registered
2014-01-20
Start date
2014-01-20
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

StageII(high risk) and stageIIIa resectable colorectal cancer

Interventions

Capecitabine 5-days on/ 2-days off schedule

Sponsors

Tsukasa Hotta
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Histopathological diagnosis of stage II(high risk) and IIIa colorectal cancer 2.curable resection 3.more than 20 yeras old 4.ECOG Performance Status 0-2 5.WBC more than 3000/mm3, neutrophil more than 1500/mm3, Platelet more than 10x104/mm3, Hb more than 9g/dL, TBil less than 1.5mg/dL, AST and ALT less than 100IU/L Cr less than 1.5mg/dL, 6. it is possible to perform adjuvant chemotherapy within 8 weeks after tumor resection 7.informed consent

Exclusion criteria

Exclusion criteria: 1.Pregnant female 2.It may be pregnant state female 3.Past history of malignant disease 4.There is uncontrolled cerebrovascular disease 5.There was serious allergy for fluorouracl related drug 6.There was allergy due to the lack of DPD 7.There is uncontrorable infection disease 8.It is difficult to intake oral food 9.Judgementof study controlled doctor

Design outcomes

Primary

MeasureTime frame
Occurrence rate of side effect

Secondary

MeasureTime frame
Disease free survival, safety, proportion of treatments completed, quality of life.

Countries

Japan

Contacts

Public ContactTsukasa Hotta

Wakayama Medical University, School of Medicine Second Department of Surgery

hotta@wakayama-med.ac.jp073-441-0613

Outcome results

None listed

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