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NCT02225496 · ClinicalTrials.gov registry record · Phase 2
Robotic Surgery for Oropharyngeal Squamous Cell Carcinoma
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT02225496: Clinical Trial Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT02225496 is a Phase 2 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02225496, a Phase 2 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
Standard-of-care treatment options for oropharyngeal cancer often result in long-term side effects that interfere with normal quality of life. A minimally-invasive transoral robotic surgery (TORS) approach has been developed to operate on the disease site while affecting the surrounding tissue as little as possible. Researchers think that this approach may help to control the disease and avoid such long-term side effects. The goal of this clinical research study is to learn if minimally-invasive transoral robotic surgery (TORS) can help to control HPV-positive oropharyngeal cancer. Transoral means through the mouth. The TORS approach is called the Intuitive Surgical da Vinci Surgical System. Researchers also want to learn if this surgery affects participants' ability to speak and swallow.
Primary Outcome
Primary efficacy endpoint is time to local-regional recurrence (TTLRR). TTLRR measured from surgery (using minimally-invasive Transoral Robotic Surgery (TORS)) date to first date that local-regional recurrence disease is objectively documented or to last follow-up date if local-regional recurrence has not occurred during follow-up.
Interventions
- BEHAVIORAL Questionnaires
- PROCEDURE Modified Barium Swallow (MBS)
- PROCEDURE Transoral Robotic Surgery (TORS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2014-09-23 |
| Est. Completion | 2017-12-08 |
| Phase | Phase 2 |
Why NCT02225496 stopped before completion
NCT02225496 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which Questionnaires is the first listed.
NCT02225496 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02225496 about?
NCT02225496 is a clinical study titled "Robotic Surgery for Oropharyngeal Squamous Cell Carcinoma". Standard-of-care treatment options for oropharyngeal cancer often result in long-term side effects that interfere with normal quality of life. A minimally-invasive transoral robotic surgery (TORS) approach has been developed to operate on the disease site while affecting the surrounding tissue as li...
What is the current status of trial NCT02225496?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2014-09-23. Estimated completion is 2017-12-08.
What interventions are being tested in trial NCT02225496?
The interventions under investigation include: Questionnaires (BEHAVIORAL), Modified Barium Swallow (MBS) (PROCEDURE), Transoral Robotic Surgery (TORS) (PROCEDURE).
Who is sponsoring clinical trial NCT02225496?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02225496's enrollment target sits among peer trials
1 2001st of 2000 the lowest 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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