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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 is a NA study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 43 participants.
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.
Interventions
- RADIATION Radiotherapy
- DRUG Cetuximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2011-01 |
| Est. Completion | 2019-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01663259
The ClinicalTrials.gov registry entry for NCT01663259 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan Rogel Cancer Center, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Radiotherapy is the first listed.
NCT01663259 reports 0 study locations.
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.
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