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RT With or Without Cetuximab in Treating Patients Who Have Undergone Surgery for Locally Advanced Head and Neck Cancer
NCT00956007 · View on ClinicalTrials.gov ↗
Study Summary
RATIONALE: Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor, and giving radiation therapy in higher doses over a shorter period of time, may kill more tumor cells and have fewer side effects. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether radiation therapy is more effective when given alone or together with cetuximab in treating patients with head and neck cancer that has been removed by surgery. PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with cetuximab in treating patients who have undergone surgery for locally advanced head and neck cancer.
Conditions Studied
Interventions
- RADIATION intensity-modulated radiation therapy
- BIOLOGICAL cetuximab
Study Locations (20)
California
- Sutter Cancer Centers Radiation Oncology Services-Auburn — Auburn
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park — Cameron Park
- Mercy San Juan Medical Center — Carmichael
- City of Hope — Duarte
- UC San Diego Moores Cancer Center — La Jolla
- Kaiser Permanente Los Angeles Medical Center — Los Angeles
- Los Angeles County-USC Medical Center — Los Angeles
- University of Southern California/Norris Cancer Center — Los Angeles
- Memorial Medical Center — Modesto
- Bay Area Tumor Institute CCOP — Oakland
- Pomona Valley Hospital Medical Center — Pomona
- Sutter Cancer Centers Radiation Oncology Services-Roseville — Roseville
- The Permanente Medical Group-Roseville Radiation Oncology — Roseville
- Sutter General Hospital — Sacramento
- University of California at Davis Cancer Center — Sacramento
- Mercy General Hospital Radiation Oncology Center — Sacramento
- UCSF-Mount Zion — San Francisco
- Kaiser Permanente Medical Center - Santa Clara — Santa Clara
Alabama
- University of Alabama at Birmingham — Birmingham
Arizona
- Arizona Oncology Associates-West Orange Grove — Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 702 participants |
| Start Date | 2010-03-31 |
| Est. Completion | 2029-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00956007
The ClinicalTrials.gov registry entry for NCT00956007 describes a study currently listed as active not recruiting. 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 702 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Radiation Therapy Oncology Group, which has 37 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 Head and Neck Cancer appearing as the primary indexed condition, and to 2 interventions — of which intensity-modulated radiation therapy 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: NCT00956007 reports 20 study locations spanning 3 distinct geographic areas — top geographies include California, Alabama, Arizona. 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 NCT00956007 about?
NCT00956007 is a clinical study titled "RT With or Without Cetuximab in Treating Patients Who Have Undergone Surgery for Locally Advanced Head and Neck Cancer". RATIONALE: Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor, and giving radiation therapy in higher doses over a shorter period of time, may kill more tumor cells and have fewer side effects. Monoclonal antibodies...
What is the current status of trial NCT00956007?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 702 participants. The study started on 2010-03-31. Estimated completion is 2029-08.
What conditions does trial NCT00956007 study?
This clinical trial studies the following conditions: Head and Neck Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00956007?
The interventions under investigation include: intensity-modulated radiation therapy (RADIATION), cetuximab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00956007?
This trial is sponsored by Radiation Therapy Oncology Group, which has 37 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00956007 being conducted?
This trial has 20 study locations across Alabama, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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