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Multicenter Center of Prospective Study of Combination Chemotherapy with Cetuximab In metastatic Colorectal Cancer

Multicenter Center of Prospective Study of Combination Chemotherapy with Cetuximab In metastatic Colorectal Cancer - Multicenter Center of Prospective Study of Combination Chemotherapy with Cetuximab In metastatic Colorectal Cancer

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000017396
Enrollment
42
Registered
2015-05-02
Start date
2012-09-01
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

Unresectable colorectal cancer

Interventions

None listed

Sponsors

Gastroenterological Surgery1, Hokkaido University Graduate school of medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The cases histologically diagnosed as colorectal cancer 2. The cases without a history of chemotherapy 3. The cases with evaluative cancer lesions based on RECIST 4. The cases with wild-type about KRAS status 5. The age is 20 years old and older. 6. Performance status is 0-2 cases 7. A major organ function is maintained by a laboratory study. 8. The cases could survive at least for 3 months from the registration day. 9. An agreement is obtained in a document from the patients.

Exclusion criteria

Exclusion criteria: 1. The cases with serious drug hypersensitivity or allergy 2. Multiple primary cancers 3. The cases with symptomatic brain metastasis 4. The cases with infectious disease requiring systemic therapy 5. The cases with serious complications - Interstitial pneumonia, pulmonary fibrosis - Heart failure - Renal failure - Liver failure - Poor control diabetes mellitus - Icterus 6. Pregnant or lactating women 7. The cases judged to be unsuitable for registration

Design outcomes

Primary

MeasureTime frame
Response rate

Secondary

MeasureTime frame
Resection rate, Progression free survival, Overall survival, Safety

Countries

Japan

Contacts

Public ContactNorihiko Takahashi

Hokkaido University Hospital Gastroenterology1

noripiko@med.hokudai.ac.jp011-706-5927

Outcome results

None listed

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