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NCT00539643 · ClinicalTrials.gov registry record · Phase 2
Trial of Beads Versus Doxorubicin Eluting Beads for Arterial Embolization of Hepatocellular Carcinoma
A Phase 2 study, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 101
- Enrollment target
NCT00539643: Completed Phase 2 study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT00539643 is a Phase 2 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 101 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00539643, a Phase 2 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 101 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effect of blocking the blood vessels to the tumor in your liver with small beads alone (Bead Block) versus blocking them with the same bead that contains and releases doxorubicin (a chemotherapy agent). The reason for the study is to see if adding doxorubicin kills more tumor than would be killed by just blocking the blood supplying the tumor. The chemotherapy, doxorubicin, has been used for many years to treat patients with cancer. This procedure to block the blood vessels is called embolization. Embolization is a common treatment for patients with liver cancer who cannot have surgery. The investigators are comparing the standard treatment (using the small beads alone) with another that should be at least as good, but possibly better (with the addition of the drug, doxorubicin). There is no guarantee that the new treatment is better and it is possible that there might be more side effects (related to the doxorubicin) than what is seen with the standard treatment.
Primary Outcome
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Interventions
- DEVICE Bead Block microspheres
- OTHER Bead + Dox Arm
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2007-11 |
| Est. Completion | 2022-06-17 |
| Phase | Phase 2 |
What the finished NCT00539643 record still lists
NCT00539643 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% lower).
The record links to 0 conditions, and to 2 interventions - of which Bead Block microspheres is the first listed.
NCT00539643 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00539643 about?
NCT00539643 is a clinical study titled "Trial of Beads Versus Doxorubicin Eluting Beads for Arterial Embolization of Hepatocellular Carcinoma". The purpose of this study is to evaluate the effect of blocking the blood vessels to the tumor in your liver with small beads alone (Bead Block) versus blocking them with the same bead that contains and releases doxorubicin (a chemotherapy agent). The reason for the study is to see if adding doxorub...
What is the current status of trial NCT00539643?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 101 participants. The study started on 2007-11. Estimated completion is 2022-06-17.
What interventions are being tested in trial NCT00539643?
The interventions under investigation include: Bead Block microspheres (DEVICE), Bead + Dox Arm (OTHER).
Who is sponsoring clinical trial NCT00539643?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00539643's enrollment target sits among peer trials
101 672nd of 2000 higher than 1,329 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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