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Effective and safe examination of the mFOLFOX6/panitumumab combination therapy for the purpose of hepatectomizing in patients with KRAS Wild-type advanced colorectal cancer which has unresectable liver metastases - Phase II study -

Effective and safe examination of the mFOLFOX6/panitumumab combination therapy for the purpose of hepatectomizing in patients with KRAS Wild-type advanced colorectal cancer which has unresectable liver metastases - Phase II study - - mFOLFOX6+Pmab NAC Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011674
Enrollment
32
Registered
2013-09-13
Start date
2013-09-04
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

mFOLFOX6+Pmab is repeated every 14 days until meeting the withdrawal criteria.

Sponsors

3rd department of surgery Tokyo Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients with histologically proven colorectal cancer 2.KRAS Wild-type 3.Unresectable synchronous and metachronous liver metastases 4.With measurable lesions in the liver only (no extrahepatic disease) 5.No prior chemotherapy for colorectal cancer 6.No prior radiotherapy for colorectal cancer 7.Age: 20 years old and above, 80 years old or older 8.Performance status(ECOG):0, 1 9.Life expectancy of more than 3 months 10.Sufficient organ functions 11.Written informed consent

Exclusion criteria

Exclusion criteria: 1.Not reach hepatectomizing it even if enforcement of the preoperation chemotherapy 2.Serious drug hypersensitivity or a history of drug allergy 3.Peripheral neuropathy 4.Active concomitant malignancy 5.Severe infectious disease 6.Serious complications (renal failure or hepatic failure) 7.High blood pressure and diabetic and hypercalcemia that cannot be controlled 8.Symptomatic or asymptomatic but treated heart disease 9.Symptomatic or asymptomatic but treated heart disease 10.Histry of mental disturbances or cerebrovascular attack 11.Fresh hemorrhage from digestive tube, intestines tube paralysis, intestinal obstruction and peptic ulcer 12.Plerral effusion, peritoneal fluid and pericardial fluid 13.Symptomatic brain metastasis 14.Water solubility diarrhea, in case of the patient who has a colostomy, diarrhea impairs daily life activity 15.Under coutinuous steroid therapy 16.History of organ transplantation 17.Traumatic gracture of unrecovery 18.Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers 19.Other condition not suitable for this study

Design outcomes

Primary

MeasureTime frame
Overall Response Rate

Secondary

MeasureTime frame
Resection rate of metastatic resion Liver metastases R0 resection rate Safety relapse-free survival Overall Survival

Countries

Japan

Contacts

Public ContactKenji Katsumata

Tokyo Medical University 3rd department of surgery

k-katsu@tokyo-med.ac.jp03-3342-6111

Outcome results

None listed

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