Chemoembolization, Irinotecan Bead, Second Line Chemotherapy Treatment of Unresectable Metastatic Colorectal Cancer

Conditions

• Unresectable Metastatic Colo-rectal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Chemoembolization with irinotecan Bead — PROCEDURE
  Intra arterial chemoembolization using Irinotecan Bead 100mg irinotecan per procedure in combination with irinotecan monotherapy 250mg/m2 alternating on a 3 weekly schedule
• Irinotecan — DRUG
  Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks

Study Details

The primary objective of this study is to evaluate the safety and efficacy of Irinotecan Bead in combination with intravenous chemotherapy versus intravenous chemotherapy alone in the treatment of unresectable liver metastases in patients with colorectal cancer. The results of this study are intended to be used in support of a PMA application for a combination device

Key Dates

Start date

Dec 31, 2008

Status verified

Feb 2018

Primary completion

Jan 31, 2011

Completion

Mar 31, 2011

Study Design

Enrollment

4 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Chemoembolization
  Chemoembolization with Irinotecan Bead in combination with Intravenous Chemotherapy Group (test arm)
• Active Comparator: Chemotherapy
  Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks

Primary Outcome Measure

Progression Free Survival [ Time Frame: 1 year ]

Locations (3)

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