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NCT00932438 · ClinicalTrials.gov registry record · Phase 1

Drug-Eluting Bead, Irinotecan (DEBIRI) Therapy of Liver Metastasis From Colon Cancer With Systemic Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab

A Phase 1 study, sponsored by University of Louisville.

Completed
Registry status
Phase 1
Development phase
70
Enrollment target

NCT00932438: Completed Phase 1 study, sponsored by University of Louisville.

NCT00932438 is a Phase 1 study that has completed, run by University of Louisville. The registered enrollment target is 70 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00932438, a Phase 1 study, has completed, sponsored by University of Louisville.

COMPLETED
Registry status
Phase 1
Development phase
70 participants
Enrollment target

Study Summary

This is a multicentre, open labeled, controlled phase study designed to assess effectiveness of chemoembolization with LC Beads, both with and without systemic chemotherapy, in the treatment of unresectable liver metastases in patients with colorectal cancer.

Primary Outcome

Tumor response will be determined using Modified Response Evaluation Criteria in Solid Tumors (mRECIST). Response will classified as: Complete response - disappearance of all lesions; Partial response - at least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter or 30% reduction of arterial enhancement; Progressive disease - at least 20% increase in the sum of the longest diameter of target lesions, taking as reference the

Interventions

  • DRUG Bevacizumab
  • DRUG Leucovorin
  • DRUG Oxaliplatin
  • DRUG 5-Fluorouracil
  • DEVICE LC beads loaded with Irinotecan

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2009-06
Est. Completion 2012-12
Phase Phase 1
University of Louisville

217 total trials

What the finished NCT00932438 record still lists

NCT00932438 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher).

The record links to 0 conditions, and to 5 interventions - of which Bevacizumab is the first listed.

NCT00932438 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00932438 about?

NCT00932438 is a clinical study titled "Drug-Eluting Bead, Irinotecan (DEBIRI) Therapy of Liver Metastasis From Colon Cancer With Systemic Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab". This is a multicentre, open labeled, controlled phase study designed to assess effectiveness of chemoembolization with LC Beads, both with and without systemic chemotherapy, in the treatment of unresectable liver metastases in patients with colorectal cancer.

What is the current status of trial NCT00932438?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2009-06. Estimated completion is 2012-12.

What interventions are being tested in trial NCT00932438?

The interventions under investigation include: Bevacizumab (DRUG), Leucovorin (DRUG), Oxaliplatin (DRUG), 5-Fluorouracil (DRUG), LC beads loaded with Irinotecan (DEVICE).

Who is sponsoring clinical trial NCT00932438?

This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00932438's enrollment target sits among peer trials

70 749th of 2000 higher than 1,227 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00932438, the US trial registry maintained by the National Library of Medicine. NCT00932438 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.