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NCT01302834 · ClinicalTrials.gov registry record · Phase 3
Radiation Therapy With Cisplatin or Cetuximab in Treating Patients With Oropharyngeal Cancer
A Phase 3 study of Head and Neck Cancer and Precancerous Condition, sponsored by Radiation Therapy Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 987
- Enrollment target
- 20
- Study locations
NCT01302834: Completed Phase 3 study of Head and Neck Cancer and Precancerous Condition, sponsored by Radiation Therapy Oncology Group.
NCT01302834 is a Phase 3 study of Head and Neck Cancer and Precancerous Condition that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 987 participants, above the 257-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (284% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01302834, a Phase 3 study of Head and Neck Cancer and Precancerous Condition, has completed, sponsored by Radiation Therapy Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 987 participants
- Enrollment target
- 20
- Study locations
Study Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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 with cisplatin or cetuximab in treating oropharyngeal cancer. PURPOSE: This phase III trial is studying radiation therapy with cisplatin or cetuximab to see how well it works in treating patients with oropharyngeal cancer.
Primary Outcome
An event for overall survival is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. The protocol endpoint is hazard ratio, which is reported in the statistical analysis results. Five-year rate is reported simply as summary data; it is not the outcome measure.
Conditions Studied
Interventions
- DRUG cisplatin
- RADIATION IMRT
- BIOLOGICAL cetuximab
Study Locations (20)
California
- Auburn Radiation Oncology - Auburn
- Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center - Burbank
- Radiation Oncology Centers - Cameron Park - Cameron Park
- Mercy Cancer Center at Mercy San Juan Medical Center - Carmichael
- Enloe Cancer Center at Enloe Medical Center - Chico
- City of Hope Comprehensive Cancer Center - Duarte
- Rebecca and John Moores UCSD Cancer Center - La Jolla
- Kaiser Permanente - Division of Research - Oakland - Oakland
- Rohnert Park Cancer Center - Rohnert Park
- Radiation Oncology Center - Roseville - Roseville
- Radiological Associates of Sacramento Medical Group, Incorporated - Sacramento
- Mercy General Hospital - Sacramento
- UCSF Helen Diller Family Comprehensive Cancer Center - San Francisco
- - Santa Clara
- Kaiser Permanente Medical Center - South San Francisco - South San Francisco
- Solano Radiation Oncology Center - Vacaville
Colorado
- Rocky Mountain Cancer Centers - Aurora - Aurora
- Boulder Community Hospital - Boulder
- Penrose Cancer Center at Penrose Hospital - Colorado Springs
Alaska
- Providence Cancer Center - Anchorage
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 987 participants |
| Start Date | 2011-06 |
| Est. Completion | 2025-09-04 |
| Phase | Phase 3 |
What the finished NCT01302834 record still lists
NCT01302834 is an interventional study that assigns participants to a tested intervention. The registered 987 participants enrollment target is mid-sized for trials with a published cap, above the 257-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (284% higher).
The record links to 2 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 3 interventions - of which cisplatin is the first listed.
NCT01302834 names 20 study sites across 3 states, led by California, Colorado, Alaska.
Frequently Asked Questions
What is clinical trial NCT01302834 about?
NCT01302834 is a clinical study titled "Radiation Therapy With Cisplatin or Cetuximab in Treating Patients With Oropharyngeal Cancer". RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab...
What is the current status of trial NCT01302834?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 987 participants. The study started on 2011-06. Estimated completion is 2025-09-04.
What conditions does trial NCT01302834 study?
This clinical trial studies the following conditions: Head and Neck Cancer, Precancerous Condition.
What interventions are being tested in trial NCT01302834?
The interventions under investigation include: cisplatin (DRUG), IMRT (RADIATION), cetuximab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01302834?
This trial is sponsored by Radiation Therapy Oncology Group, which has 144 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01302834 being conducted?
This trial has 20 study locations across Alaska, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT01302834's enrollment target sits among peer trials
987 12th of 250 higher than 239 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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