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Efficacy Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Platinum-Refractory Head and Neck Cancers
NCT01166542 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this Phase 3 study is to evaluate overall survival and progression free survival following intravenous administration of REOLYSIN (Reovirus Serotype 3 Dearing) in combination with paclitaxel and carboplatin versus chemotherapy treatment alone, in patients with metastatic or recurrent Squamous Cell Carcinoma of the Head and Neck.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Placebo
- DRUG Paclitaxel
- BIOLOGICAL REOLYSIN
Study Locations (20)
California
- Providence Health and Services — Burbank
- Wilshire Oncology Medical Group — Corona
- BMS Physician Practice, A Medical Corporation DBA Medical Oncology Care Associates — Orange
Texas
- Texas Oncology- Sammons Cancer Center — Dallas
- Cancer Therapy and Research Center at UTHSCSA — San Antonio
- Texas Oncology - Tyler — Tyler
Ohio
- Case Comprehensive Cancer Center, University Hospitals Case Medical Center — Cleveland
- Mercy Cancer Center — Toledo
Alabama
- University of Alabama at Birmingham — Birmingham
Arizona
- Arizona Oncology Associates — Tucson
Colorado
- Rocky Mountain Cancer Centers — Denver
Florida
- Pasco Hernando Oncology Associates, PA — New Port Richey
Georgia
- Emory University - Winship Cancer Institute — Altanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 167 participants |
| Start Date | 2010-06 |
| Est. Completion | 2014-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01166542
The ClinicalTrials.gov registry entry for NCT01166542 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 167 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oncolytics Biotech, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Carcinoma, Squamous Cell of the Head and Neck appearing as the primary indexed condition, and to 4 interventions — of which Carboplatin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01166542 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Texas, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01166542 about?
NCT01166542 is a clinical study titled "Efficacy Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Platinum-Refractory Head and Neck Cancers". The purpose of this Phase 3 study is to evaluate overall survival and progression free survival following intravenous administration of REOLYSIN (Reovirus Serotype 3 Dearing) in combination with paclitaxel and carboplatin versus chemotherapy treatment alone, in patients with metastatic or recurrent ...
What is the current status of trial NCT01166542?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 167 participants. The study started on 2010-06. Estimated completion is 2014-05.
What conditions does trial NCT01166542 study?
This clinical trial studies the following conditions: Carcinoma, Squamous Cell of the Head and Neck. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01166542?
The interventions under investigation include: Carboplatin (DRUG), Placebo (DRUG), Paclitaxel (DRUG), REOLYSIN (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01166542?
This trial is sponsored by Oncolytics Biotech, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01166542 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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