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NCT01578239 · ClinicalTrials.gov registry record · Phase 3
A Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours
A Phase 3 study, sponsored by Advanced Accelerator Applications.
- Completed
- Registry status
- Phase 3
- Development phase
- 231
- Enrollment target
NCT01578239: Completed Phase 3 study, sponsored by Advanced Accelerator Applications.
NCT01578239 is a Phase 3 study that has completed, run by Advanced Accelerator Applications. The registered enrollment target is 231 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01578239, a Phase 3 study, has completed, sponsored by Advanced Accelerator Applications.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 231 participants
- Enrollment target
Study Summary
This was a multicenter, stratified, open, randomized, comparator-controlled, parallel-group phase III study comparing treatment with Lutathera plus best supportive care (30 mg Octreotide LAR) to treatment with high dose (60 mg) Octreotide LAR in participants with metastasized or locally advanced, inoperable, somatostatin receptor positive, histologically proven midgut carcinoid tumours with progression despite LAR treatment.
Primary Outcome
Progression Free Survival (PFS) was defined as the time from randomization to documented centrally assessed disease progression, as evaluated by the Independent Review Committee (IRC), or death due to any cause. If a participant had no centrally assessed progression and had not died at the time of the primary endpoint analysis, the participant was regarded as censored in the context of a time to event analysis at the date of last evaluable tumor assessment. Disease progression was determined by
Interventions
- DRUG Octreotide LAR
- DRUG 177Lu-DOTA0-Tyr3-Octreotate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 231 participants |
| Start Date | 2012-09-06 |
| Est. Completion | 2021-01-18 |
| Phase | Phase 3 |
What the finished NCT01578239 record still lists
NCT01578239 is an interventional study that assigns participants to a tested intervention. The registered 231 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Octreotide LAR is the first listed.
NCT01578239 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01578239 about?
NCT01578239 is a clinical study titled "A Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours". This was a multicenter, stratified, open, randomized, comparator-controlled, parallel-group phase III study comparing treatment with Lutathera plus best supportive care (30 mg Octreotide LAR) to treatment with high dose (60 mg) Octreotide LAR in participants with metastasized or locally advanced, in...
What is the current status of trial NCT01578239?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 231 participants. The study started on 2012-09-06. Estimated completion is 2021-01-18.
What interventions are being tested in trial NCT01578239?
The interventions under investigation include: Octreotide LAR (DRUG), 177Lu-DOTA0-Tyr3-Octreotate (DRUG).
Who is sponsoring clinical trial NCT01578239?
This trial is sponsored by Advanced Accelerator Applications, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01578239's enrollment target sits among peer trials
231 1300th of 2000 higher than 697 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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