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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 is a Phase 3 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 42 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01687413
The ClinicalTrials.gov registry entry for NCT01687413 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cisplatin is the first listed.
NCT01687413 reports 0 study locations.
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.
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