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NCT01687413 · ClinicalTrials.gov registry record · Phase 3
Post Operative Adjuvant Therapy De-intensification Trial for Human Papillomavirus-related, p16+ Oropharynx Cancer
A Phase 3 study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- Phase 3
- Development phase
- 42
- Enrollment target
NCT01687413: Clinical Trial Phase 3 study, sponsored by Washington University School of Medicine.
NCT01687413 is a Phase 3 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 42 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01687413, a Phase 3 study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 42 participants
- Enrollment target
Study Summary
This clinical trial studies the intensity of adjuvant ("helper") therapy required in p16 positive oropharynx cancer patients, who have had all known disease removed surgically by a minimally invasive approach, and who have extracapsular spread in their lymph nodes. Patients can consent to participate in either the randomized (physician chooses radiotherapy arm or radiotherapy \& cisplatin arm) or non-randomized (patient chooses radiotherapy arm or radiotherapy \& cisplatin arm) pathways. After the surgery, receive either radiation alone, or radiation and weekly cis-platinum during therapy. Patients are then followed for cancer, functional and quality of life outcomes.
Interventions
- DRUG Cisplatin
- RADIATION Intensity-modulated radiation therapy (IMRT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2013-01-10 |
| Est. Completion | 2019-10-18 |
| Phase | Phase 3 |
Why NCT01687413 stopped before completion
NCT01687413 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Cisplatin is the first listed.
NCT01687413 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01687413 about?
NCT01687413 is a clinical study titled "Post Operative Adjuvant Therapy De-intensification Trial for Human Papillomavirus-related, p16+ Oropharynx Cancer". This clinical trial studies the intensity of adjuvant ("helper") therapy required in p16 positive oropharynx cancer patients, who have had all known disease removed surgically by a minimally invasive approach, and who have extracapsular spread in their lymph nodes. Patients can consent to participat...
What is the current status of trial NCT01687413?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 42 participants. The study started on 2013-01-10. Estimated completion is 2019-10-18.
What interventions are being tested in trial NCT01687413?
The interventions under investigation include: Cisplatin (DRUG), Intensity-modulated radiation therapy (IMRT) (RADIATION).
Who is sponsoring clinical trial NCT01687413?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01687413's enrollment target sits among peer trials
42 1877th of 2000 higher than 124 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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