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NCT02015754 · ClinicalTrials.gov registry record · Phase 2
Irinotecan -Eluting LC Bead-M1 (DEBIRI-M1) for Patients With Liver Metastases From Colorectal Cancer
A Phase 2 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT02015754 is a Phase 2 study that has completed, run by Yale University. The registered enrollment target is 14 participants.
The verdict
NCT02015754, a Phase 2 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
Study Summary
Purpose: The purpose of this study is to determine the feasibility and safety of using small beads (70-150 micron in place of 100-300 micron) to deliver chemotherapy into the liver to treat patients with liver lesions from colorectal cancer. The beads (LC-Bead M1) will be loaded with irinotecan (DEBIRI-M1), and used to administer transarterial chemoembolization (TACE). Eligibility: Patients with liver cancer from colorectal cancer. Study Overview/ Treatment: DEBIRI, loaded with irinotecan, is a device that utilizes tiny beads (70-150 microns) to deliver chemotherapy agents into liver tumor(s) via the hepatic artery. This device allows for continuous release of irinotecan into the liver tumor tissue(s) causing necrosis of the targeted tumor(s). The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. Response to therapy will be evaluated monthly by clinic visits and blood tests (to include assessment of liver function and tumor markers) and by imaging (usually MRIs) every 1-2 months. Patients will be on study for 6 months after which they will be exited from the study and followed for survival. Once exited from the study they will continue to be eligible to receive DEBIRI, should it be recommended.
Interventions
- PROCEDURE TACE
- DRUG DEBIRI
- DEVICE LC Bead M1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2014-02 |
| Est. Completion | 2016-12-13 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02015754
The ClinicalTrials.gov registry entry for NCT02015754 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which TACE is the first listed.
NCT02015754 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02015754 about?
NCT02015754 is a clinical study titled "Irinotecan -Eluting LC Bead-M1 (DEBIRI-M1) for Patients With Liver Metastases From Colorectal Cancer". Purpose: The purpose of this study is to determine the feasibility and safety of using small beads (70-150 micron in place of 100-300 micron) to deliver chemotherapy into the liver to treat patients with liver lesions from colorectal cancer. The beads (LC-Bead M1) will be loaded with irinotecan (DE...
What is the current status of trial NCT02015754?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2014-02. Estimated completion is 2016-12-13.
What interventions are being tested in trial NCT02015754?
The interventions under investigation include: TACE (PROCEDURE), DEBIRI (DRUG), LC Bead M1 (DEVICE).
Who is sponsoring clinical trial NCT02015754?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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