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NCT01663259 · ClinicalTrials.gov registry record · NA
Reduced-intensity Therapy for Oropharyngeal Cancer in Non-smoking HPV-16 Positive Patients
A NA study, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- NA
- Development phase
- 43
- Enrollment target
NCT01663259: Completed NA study, sponsored by University of Michigan Rogel Cancer Center.
NCT01663259 is a NA study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 43 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01663259, a NA study, has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 43 participants
- Enrollment target
Study Summary
Taking into account the excellent prognosis of patients with HPV-positive oropharyngeal cancer with \< 10 pack-year smoking, the investigators hypothesize that reducing the intensity of therapy for these patients will reduce treatment sequelae, notably long-term dysphagia, without affecting their cure rates. The main Aim is to assess whether reducing treatment intensity, by replacing concurrent chemotherapy with cetuximab, will indeed achieve improved long-term toxicity. The primary objectives include the following: to confirm that reducing treatment intensity in patients with HPV-related oropharyngeal cancer and \< 10 pack-year smoking history by replacing concurrent chemotherapy with concurrent cetuximab, does not significantly increase the proportion of patients whose tumors recur, compared to our previous experience in similar patients receiving chemo-RT and to compare the toxicity in patients receiving cetuximab-RT to similar patients treated with 7 weeks of chemotherapy concurrent with RT ("standard therapy") in UMCC 2-21.
Primary Outcome
Number of patients whose tumors recur (includes local, regional, and distant recurrence; and second primaries). Note: Research indicates that freedom from local and regional progression (FFLRP) is a more meaningful measure. Therefore, the percentage of patients with FFLRP is included below as a Post-Hoc measure.
Interventions
- RADIATION Radiotherapy
- DRUG Cetuximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2011-01 |
| Est. Completion | 2019-09 |
| Phase | NA |
What the finished NCT01663259 record still lists
NCT01663259 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Radiotherapy is the first listed.
NCT01663259 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01663259 about?
NCT01663259 is a clinical study titled "Reduced-intensity Therapy for Oropharyngeal Cancer in Non-smoking HPV-16 Positive Patients". Taking into account the excellent prognosis of patients with HPV-positive oropharyngeal cancer with \< 10 pack-year smoking, the investigators hypothesize that reducing the intensity of therapy for these patients will reduce treatment sequelae, notably long-term dysphagia, without affecting their cu...
What is the current status of trial NCT01663259?
This trial is currently completed. It is a NA study. The enrollment target is 43 participants. The study started on 2011-01. Estimated completion is 2019-09.
What interventions are being tested in trial NCT01663259?
The interventions under investigation include: Radiotherapy (RADIATION), Cetuximab (DRUG).
Who is sponsoring clinical trial NCT01663259?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01663259's enrollment target sits among peer trials
43 1435th of 2000 higher than 565 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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