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Phase II study of cetuximab plus 5-FU/LV for unresectable colorectal cancer

Phase II study of cetuximab plus 5-FU/LV for unresectable colorectal cancer - Phase II study of cetuximab plus 5-FU/LV for unresectable colorectal cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000009483
Enrollment
24
Registered
2012-12-05
Start date
2012-12-06
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

Unresectable colorectal cancer

Interventions

cetuximab plus 5-FU/LV

Sponsors

Aichi Cancer Center Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Histological proven unresectable colorectal cancer KRAS wild Measurable lesions according to RECIST criteria Following previous treatment - refractory to 5-FU - failure or refractory or intolerant of irinotecan - refractory or failure to oxaliplatin Adequate interval from previous treatments Adequate organ function Age of 20 years or older ECOG performance status 0-2 Expected more than 8 weeks survival Written informed consent from patient

Exclusion criteria

Exclusion criteria: Symptomatic brain metastasis Sever wattery diarrhea Paralytic or mechanical bowel obstruction Confirmed or suspected infection Severe pulmonary disease Severe comorbidity Pregnant or possibly pregnant, and nursing women Sever neurologic disease Receiving atazanavir sulfate Past history of monoclonal antibody sever allergy Past history of 5-FU/LV sever allergy Past history of treatment with Anti-EGFR Other conditions not suitable for this study

Design outcomes

Primary

MeasureTime frame
response rate

Secondary

MeasureTime frame
disease control rate, progression free survival, overall survival, toxicity, QOL

Countries

Japan

Contacts

Public ContactTakashi Ura

Aichi Cancer Center Hospital Department of Clinical Oncology

tura@aichi-cc.jp052-762-6111

Outcome results

None listed

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