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NCT01013623 · ClinicalTrials.gov registry record · Phase 3
Stage IV Surgery Versus Best Medical Therapy
A Phase 3 study, sponsored by Saint John's Cancer Institute.
- Terminated
- Registry status
- Phase 3
- Development phase
- 12
- Enrollment target
NCT01013623: Clinical Trial Phase 3 study, sponsored by Saint John's Cancer Institute.
NCT01013623 is a Phase 3 study that was terminated before completion, run by Saint John's Cancer Institute. The registered enrollment target is 12 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01013623, a Phase 3 study, was terminated before completion, sponsored by Saint John's Cancer Institute.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 12 participants
- Enrollment target
Study Summary
This study will establish the role of surgical versus nonsurgical approaches in patients whose melanoma has spread to distant sites. Results will help clinicians develop a standardized initial approach that prolongs survival and optimizes quality of life. Results also will indicate whether Bacillus Calmette-Guerin (BCG) postoperative immunotherapy significantly improves the outcome of patients treated with surgery.
Primary Outcome
Defined as time from randomization to death from any cause
Interventions
- PROCEDURE Surgery
- OTHER best medical therapy
- PROCEDURE Surgery plus 2 adjuvant doses of BCG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2009-11 |
| Est. Completion | 2012-09 |
| Phase | Phase 3 |
Why NCT01013623 stopped before completion
NCT01013623 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which Surgery is the first listed.
NCT01013623 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01013623 about?
NCT01013623 is a clinical study titled "Stage IV Surgery Versus Best Medical Therapy". This study will establish the role of surgical versus nonsurgical approaches in patients whose melanoma has spread to distant sites. Results will help clinicians develop a standardized initial approach that prolongs survival and optimizes quality of life. Results also will indicate whether Bacillus ...
What is the current status of trial NCT01013623?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 12 participants. The study started on 2009-11. Estimated completion is 2012-09.
What interventions are being tested in trial NCT01013623?
The interventions under investigation include: Surgery (PROCEDURE), best medical therapy (OTHER), Surgery plus 2 adjuvant doses of BCG (PROCEDURE).
Who is sponsoring clinical trial NCT01013623?
This trial is sponsored by Saint John's Cancer Institute, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01013623's enrollment target sits among peer trials
12 1984th of 2000 higher than 12 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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