Role of Thymidine Phosphorylase(TP), Dihydropyrimidine Dehydrogenase(DPD)and Thymidylate synthase(TS)for Predicting the Prognosis and Therapeutic Effects of Doxifluridine, An Intermediate form of Capecitabine, in adjuvant therapy for postoperative Node positive colorectal cancer(DukesC); Findings from a multicenter Phase2 trial.

Role of Thymidine Phosphorylase(TP), Dihydropyrimidine Dehydrogenase(DPD)and Thymidylate synthase(TS)for Predicting the Prognosis and Therapeutic Effects of Doxifluridine, An Intermediate form of Capecitabine, in adjuvant therapy for postoperative Node positive colorectal cancer(DukesC); Findings from a multicenter Phase2 trial. - Role of Thymidine Phosphorylase(TP), Dihydropyrimidine Dehydrogenase(DPD)and Thymidylate synthase(TS) in adjuvant therapy of Capecitabine for postoperative Node positive colorectal cancer(DukesC).

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000077

Enrollment

300

Registered

2006-01-01

Start date

2001-11-01

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

Dukes'C colorectal cancer which is removed curatively and surgically

Interventions

chemotherapy(Doxifluridine:5'-DFUR)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histologically confirmed adenocarcinoma undergone radical operation and classified into Dukes'C Performance status of 0, 1, or 2 Patient age is more than 20 and less than 75 Oral administration of 5'-DFUR is possible Fresh specimens of colorectal cancer were obtained No previous treatment except for resection Adequate bone marrow reserve, hepatic, renal functions, and normal cardiac function within six weeks after the operation Written informed consent is required to obtain from each patient at each participating institution

Exclusion criteria

Exclusion criteria: appendiceal carcinoma and anal canal carcinoma of anal gland origin Multiple cancer patients except m cancer apparent infection sever postoperative complications active peptic ulcer Cardiac infarction within three months-uncontrolled hypertension -diabetes mellitus, uncontrolled or controlled with insulin -unstable angina, myocardial infarction needed to treat or febrile neutropenia

Design outcomes

Primary

Measure	Time frame
Disease-free survival	—

Secondary

Measure	Time frame
Overall survival	—

Countries

Japan

Contacts

Public ContactHirofumi Yamamoto

Multicenter Clinical Study Group of Osaka,Colorectal Cancer Treatment Group Coordinating Office

hyamamoto@gesurg.med.osaka-u.ac.jp06-6879-3251

Outcome results

None listed

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