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A randomized controlled trial comparing capecitabine 5-days-on/2-days-off regimen with conventional regimen in stage II and III colorectal cancer.

A randomized controlled trial comparing capecitabine 5-days-on/2-days-off regimen with conventional regimen in stage II and III colorectal cancer. - A randomized clinical trial of capecitabine 5-days-on/2-days-off regimen or conventional regimen in colorectal cancer.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000032865
Enrollment
110
Registered
2018-06-20
Start date
2018-06-30
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 stageIII resectable colorectal cancer

Interventions

Capecitabine 5-days on/ 2-days off schedule Capecitabine conventional schedule

Sponsors

Wakayama Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Histopathological diagnosis of colorectal cancer 2.Postoperative adjuvant chemotherapy is scheduled after colorectal cancer resection in Stage II and III. 3. Chemotherapy of capecitabine is scheduled as postoperative adjuvant chemotherapy. 4.Age:20-80 years old 5.ECOG Performance Status 0-1 6. i)WBC more than 3000/mm3, ii) neutrophil more than 1500/mm3, iii) Platelet more than 10x10^4/mm3, iv) Hb more than 9g/dL, v) TBil less than 1.5mg/dL, vi) AST and ALT less than 100IU/L vii) Cr less than 1.5mg/dL, 7.chemotherapy has not been administered for the target disease 8.informed consent

Exclusion criteria

Exclusion criteria: 1. duplicated active cancer 2. history of severe drug hypersensitivity 3. clinically problematic infection 4. it is judged that registration in this study is difficult due to clinically problematic mental / neurological diseases 5. any of the following complications i) diabetes with poor control ii) hypertension with poor control iii) interstitial pneumonia or pulmonary fibrosis iv) intestinal palsy or intestinal obstruction v) clinically problematic heart disease 6. already undergoing other chemotherapy before and after surgery 7. temporary ileostomy/colostomy closure is scheduled and the administration period of continuous 24 weeks is interrupted for a long time (8) Other cases that the doctor in charge judged unsuitable for safely carrying out this study.

Design outcomes

Primary

MeasureTime frame
feasibility

Countries

Japan

Contacts

Public ContactYuki Mizumoto

Wakayama Medical University Second Department of Surgery

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

Outcome results

None listed

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