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A feasibility study of adjuvant therapy with UFT/Leucovorin+Oxaliplatin following curative resection for stage III colorectal cancer

A feasibility study of adjuvant therapy with UFT/Leucovorin+Oxaliplatin following curative resection for stage III colorectal cancer - A feasibility study of adjuvant therapy with TEGAFOX following curative resection for stage III colorectal cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000016007
Enrollment
74
Registered
2014-12-19
Start date
2014-11-26
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

Colorectal cancer

Interventions

UFT 300mg per m2 per day and LV 75mg per day for 28 days Oxaliplatin:85mg/m2 day1,15 every 35 days for 5-cycle

Sponsors

Gunma University Graduate School
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Histologically proven stage III colorectal cancer (Adenocarcinoma) 2. Pathological curability is A 3. Aged at the time of registration at least 20 yewas of age 4. Performance status(ECOG) :0,1 5. Adequate organ function 6. Able to start between 8 weeks after surgery 7. Able to receive oral treatment 8. Written IC

Exclusion criteria

Exclusion criteria: 1. Multiple malignancies within five years 2. Serious complications 3. Peripheral neuropathy 4.Serious diarrhea 5. Serious drug allergy 6. Positive for HBs antigen and HCV antibody 7. Women who are pregnant, lactating, or wish to become pregnant 8. Any other cases who are regarded as inadequate for study enrollment by the investigator

Design outcomes

Primary

MeasureTime frame
Treatment completion ratio

Secondary

MeasureTime frame
Disease free survival(DFS) Overall Survival (OS) Safety profile

Countries

Japan

Contacts

Public ContactSoichi Tsutsumi

Gunma University Graduate School Department of General Surgical Science

gundai1geka@gmail.com027-220-8224

Outcome results

None listed

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