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NCT00956007 · ClinicalTrials.gov registry record · Phase 3
RT With or Without Cetuximab in Treating Patients Who Have Undergone Surgery for Locally Advanced Head and Neck Cancer
A Phase 3 study of Head and Neck Cancer, sponsored by Radiation Therapy Oncology Group.
- Active
- Registry status
- Phase 3
- Development phase
- 702
- Enrollment target
- 20
- Study locations
NCT00956007: Active Phase 3 study of Head and Neck Cancer, sponsored by Radiation Therapy Oncology Group.
NCT00956007 is a Phase 3 study of Head and Neck Cancer that is active but no longer recruiting, run by Radiation Therapy Oncology Group. The registered enrollment target is 702 participants, above the 258-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (172% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00956007, a Phase 3 study of Head and Neck Cancer, is active but no longer recruiting, sponsored by Radiation Therapy Oncology Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 702 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Overall survival time is defined as time from registration/randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. Analysis occurred after all participants had potentially been on study for at least 5 years. The distributions of survival times are compared, which is reported in the statistical analysis results. Five-year rates are provided.
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 |
What the registry record for NCT00956007 still lists
NCT00956007 is an interventional study that assigns participants to a tested intervention. The registered 702 participants enrollment target is mid-sized for trials with a published cap, above the 258-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (172% higher).
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.
NCT00956007 names 20 study sites across 3 states, led by California, Alabama, Arizona.
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.
What interventions are being tested in trial NCT00956007?
The interventions under investigation include: intensity-modulated radiation therapy (RADIATION), cetuximab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00956007?
This trial is sponsored by Radiation Therapy Oncology Group, which has 144 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Head and Neck Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00956007's enrollment target sits among peer trials
702 17th of 250 higher than 234 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Cancer 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.
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