A feasibility study of capecitabine and oxaliplatin (XELOX) for patients with stage II/III colon cancer.

A feasibility study of capecitabine and oxaliplatin (XELOX) for patients with stage II/III colon cancer. - ACTOR study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008029

Enrollment

Registered

2012-06-01

Start date

2012-06-01

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

colorectal cancer

Interventions

XELOX Capecitabine:2000mg/m2 d1-14 Oxaliplatin:130mg/m2 d1 Q3w

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histological confirmation of stage II/III colorectal cancer. 2. Prior surgical resection with D2 or greater lymphadenectomy. 3. Surgical diagnosis as Cur A. 4. Adjuvant chemotherapy is planned within 8 weeks after surgery. 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. 6. No history of prior chemotherapy or radiation. 7. Age of 20 years or older. 8. Capable of oral intake. 9. Vital organ functions (listed below) are preserved within 2 weeks prior to entry i. WBC4000/mm3 or greater (12,000/mm3 or lesser) ii. Neurtophils: 2000/mm3 or greater iii. Platelets: 100,000/mm3 or greater iv. Hemoglobin: 9.0g/dl or greater v. AST and ALT: upper limit of normal (ULN)*2.5 or lesser. vi. Total bilirubin: upper limit of normal (ULN)*2 or lesser. vi. Serum creatinine: upper limit of normal (ULN)*1.25 or lesser. 10. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Severe peripheral sensory neuropathy 2. History of the serious hypersensitivity for drugs. 3. Active infection. 4. Complications (Evidence of interstinal lung disease, or pulmonary fibrosis, paralytic or mechanical bowel obstruction, uncontrolled hypertension, uncontrolled diabetes mellitus, cirrhosis, active cardiovascular disease, or past or current history (within 3 months) of myocardial infarction. 5. Multiple primary cancer within 5years. 6. Uncontrolled diarrhea. 7. Clinically significant mental or psychological disease. 8. Pregnancy, lactation period. 9. Other conditions not suitable for this study

Design outcomes

Primary

Measure	Time frame
Completion rate of treatment	—

Secondary

Measure	Time frame
1 Completion rate of L-OHP 2 Disease-free survival 3 Recurrent-free survival 4 Overall survival 5 Adverse effect 6 Correlation of relative dose intensity with prognosis 7 Correlation of stage with prognosis	—

Countries

Japan

Contacts

Public ContactMitsukuni Suenaga

The Cancer Institute Hospital of JFCR Gastroenterology

m.suenaga@jfcr.or.jp+81-3-3520-0111

Outcome results

None listed

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