A phase II study of Oxaliplatin Reintroduction in patients pretreated with Oxaliplatin and Irinotecan for Advanced Colorectal Cancer

A phase II study of Oxaliplatin Reintroduction in patients pretreated with Oxaliplatin and Irinotecan for Advanced Colorectal Cancer - A phase II study of Oxaliplatin Reintroduction in patients pretreated with Oxaliplatin and Irinotecan (RE-OPEN study)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004884

Enrollment

Registered

2011-02-01

Start date

2011-02-01

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

Metastatic colorectal cancer

Interventions

mFOLFOX6 5FU bolus: 400 mg/m2 d1 5FU infusion: 2400 mg/m2/46h d1 Oxaliplatin: 85mg/m2 d1 l-LV: 200mg/m2 d1 Q2w

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histological confirmation of colorectal cancer. 2. Achieved tumor response (PR or CR) or stable disease (SD) during prior oxaliplatin-based therapy. 3. Six months or over from confirmed progression disease during previous oxaliplatin-based therapy. 4. Treatment history of previous irinotecan-based chemotherapy. 5. Measurable or evaluable disease (RECIST ver.1.1.) 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2. 7. Age of 20 years or older. 8. Life expectancy greater than or equal to 3 months 12 weeks. 9. Vital organ functions (listed below) are preserved within 2 weeks prior to entry. i. Neurtophils > or =1500/mm3 ii. Platelets> or =100,000/mm3 iii. Hemoglobin> or =9.0g/dl iv. AST and ALT = or <upper limit of normal (ULN)*2.5 (= or <ULN*5 in case of liver metastasis) v. Total bilirubin = or <upper limit of normal (ULN)*1.5 vi. Serum creatinine = or <upper limit of normal (ULN)*1.5 10. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Severe peripheral neuropathy. 2. History of the serious hypersensitivity for drugs. 3. Active infection. 4. Complications (Evidence of interstinal lung disease, emphysema, 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, uncontrolled angina pectoris or arrythmia. 5. Multiple primary cancer within 5years. 6. Need to drain pleural effusion, ascites or pericardial effusion. 7. Uncontrolled diarrhea. 8. Radiological evidence of brain cancer. 9. Clinically significant mental or psychological disease. 10. Other conditions not suitable for this study.

Design outcomes

Primary

Measure	Time frame
Disease control rate after 12 weeks of treatment.	—

Secondary

Measure	Time frame
Adverse Effect Response Rate Progression-Free Survival Overall Survival	—

Countries

Japan

Contacts

Public ContactMitsukuni Suenaga

The cancer institute hospital of JFCR Gastroenterological center

m.suenaga@jfcr.or.jp03-3520-0111

Outcome results

None listed

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