Chemoembolisation With CPT11 Loaded DC Bead With Cetuximab and 5FU/LV in First Line in Patients With KRAS Wildtype mCRC

Sponsor
Universitaire Ziekenhuizen KU Leuven
Study ID
NCT01631539
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DC Bead™ — DEVICE
    chemoembolization with DC Bead™ loaded with Irinotecan
  • Cetuximab — DRUG
    400 mg/m² IV at day 1 followed by 250 mg/m² IV weekly
  • 5 FU — DRUG
    every 2 weeks IV
  • Irinotecan — DRUG
    every 4 weeks chemoembolization

Study Details

The purpose of this study is to assess feasibility of chemoembolization with DC Bead loaded with Irinotecan in combination with Cetuximab and 5FU/LV as a first line treatment for wildtype KRAS unresectable liver metastases from colorectal cancer.

Key Dates

Start date
Sep 30, 2012
Status verified
Dec 2014
Primary completion
Dec 31, 2014
Completion
Dec 31, 2014

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Chemoembolization
    chemoembolization with DC Bead™ loaded with Irinotecan

Primary Outcome Measure

Feasibility of chemoembolization with DC Bead loaded with Irinotecan [ Time Frame: after one cycle = after 8 weeks ]

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