Efficacy and Safety study of adjuvant therapy with capecitabine plus oxaliplatin (XELOX) for the Japanese patient with Stage III curative resection Colon cancer -Phase II study

Efficacy and Safety study of adjuvant therapy with capecitabine plus oxaliplatin (XELOX) for the Japanese patient with Stage III curative resection Colon cancer -Phase II study - Efficacy and Safety study of adjuvant therapy with XELOX for the Japanese patient with StageIII curative resection Colon cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006742

Enrollment

140

Registered

2011-11-20

Start date

2011-11-10

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

Colon cancer

Interventions

Adjuvant chemotherapy with capecitabine plus oxaliplatin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically proved colon cancer(adenocarcinoma) 2) Stage III colon cancer or RS 3) >=D2 lymph node dissection 4) Pathological curability is A 5) >=20years-old 6) ECOG performance status 0-1 7) No prior chemotherapy or radiotherapy 8) Enough oral food intake possible 9) Adequate organ function 10) Able to start within 8 weeks after surgery 11) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Present with diarrhea 2) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ 3) CTCAE v4.0>Grade1 of peripheral neuropathy 4) regular use of insulin 5) uncontrollable congestive heart failure, angina,hypertension, arrhythmia 6) Severe mental disease 7) active infection 8) Pregnant or breast-feeding women 9) Woman might be pregnant 10) Inadequate physical condition, as diagnosed by primary physician

Design outcomes

Primary

Measure	Time frame
3 year disease free survival	—

Secondary

Measure	Time frame
Completion rate of treatment,Safety, Duration of administration of oxaliplatin, Incidence of Peripheral neuropathy and hand foot syndrome, Incidence and Survival of hand foot syndrome, dose intensity,Efficacy of Stage IIIa, IIIb	—

Countries

Japan

Contacts

Public ContactMamoru Uemura

Osaka University Graduate School of Medicine Department of Surgery

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

Outcome results

None listed

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