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A trial of prospective adjuvant chemotherapy in patients with resectable colorectal cancer with heaptic metastasis

A trial of prospective adjuvant chemotherapy in patients with resectable colorectal cancer with heaptic metastasis - A trial of prospective adjuvant chemotherapy in patients with resectable colorectal cancer with heaptic metastasis

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000014492
Enrollment
40
Registered
2014-07-07
Start date
2012-09-10
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

Resectable colorectal cancer with hepatic metastasis

Interventions

UFT/UZEL

Sponsors

Gastroenterological Surgery I, Hokkaido University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Colorectal cancer is hitologically diagnosed 2. Synchronous or metachronous liver metastasis is diagnosed 3. There are no distant metastasis, recurrence except liver on CT within 4 weeks before liver resection 4. Curative resection (R0)is performed 5. The age is between 20 years old and 80 years old at the registration day. 6. Performance status is 0-2 cases. 7. The oral intake of the drug is possible. 8. A major organ function is maintained by a laboratory study within 14 days before registration. 9. An agreement is obtained in a document from the patients.

Exclusion criteria

Exclusion criteria: 1. multiple primary cancer 2. Serious postoperative complications 3. Case with the following complications -Poor control diabetes mellitus -Poor control hypertention -Myocardial infarction or unstable angina within six months. -Interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema 4. Case with the following -A pregnant woman or the women who may be pregnant or hope to be pregnant -lactating women 5. The patients complicated with psychosis or neurologic manifestation, and judged to have difficulty in participation in clinical trials. 6. The case judged to be unsuitable for registration

Design outcomes

Primary

MeasureTime frame
Disease Free Survival

Secondary

MeasureTime frame
Overall Survival, Relapse Free Survival, Safety, the ratio of the patients who completed the course of UFT/UZEL, Quality of Life

Countries

Japan

Contacts

Public ContactHideki Yokoo

Hokkaido University Graduate School of Medicine Gastroenterological Surgery I

hi-yokoo@mua.biglobe.ne.jp011-706-5927

Outcome results

None listed

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