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NCT00047008 · ClinicalTrials.gov registry record · Phase 3
Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Head and Neck Cancer
A Phase 3 study of Head and Neck Cancer, sponsored by Radiation Therapy Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 743
- Enrollment target
- 20
- Study locations
NCT00047008: Completed Phase 3 study of Head and Neck Cancer, sponsored by Radiation Therapy Oncology Group.
NCT00047008 is a Phase 3 study of Head and Neck Cancer that has completed, run by Radiation Therapy Oncology Group. The registered enrollment target is 743 participants, above the 258-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (188% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00047008, a Phase 3 study of Head and Neck Cancer, has completed, sponsored by Radiation Therapy Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 743 participants
- Enrollment target
- 20
- Study locations
Study Summary
RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways and combining it with chemotherapy before surgery may kill more tumor cells. It is not yet known which radiation therapy regimen combined with chemotherapy with or without surgery is more effective for head and neck cancer. PURPOSE: Randomized phase III trial to compare two different radiation therapy regimens combined with cisplatin with or without surgery in treating patients who have stage III or stage IV head and neck cancer.
Primary Outcome
Overall survival time is defined as time from randomization to the date of death (failure) or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The full distribution is the outcome of interest, and the protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year estimates are provided as a summary of the distributions. Analysis was planned to occur after 3
Conditions Studied
Interventions
- DRUG cisplatin
- RADIATION Standard fractionation RT
- RADIATION Accelerated fractionation radiation therapy
- PROCEDURE Conventional surgery for select patients
Study Locations (20)
California
- Providence Saint Joseph Medical Center - Burbank - Burbank
- Saint Rose Hospital - Hayward
- Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital - Inglewood
- Valley Memorial Hospital - Livermore
- Loma Linda University Cancer Institute at Loma Linda University Medical Center - Loma Linda
- USC/Norris Comprehensive Cancer Center and Hospital - Los Angeles
- Providence Holy Cross Cancer Center - Mission Hills
- Highland General Hospital - Oakland
- CCOP - Bay Area Tumor Institute - Oakland
- Summit Medical Center - Oakland
- Pomona Valley Hospital Medical Center - Pomona
- Radiological Associates of Sacramento Medical Group, Inc. - Sacramento
- University of California Davis Cancer Center - Sacramento
- Naval Medical Center - San Diego - San Diego
Arizona
- Foundation for Cancer Research and Education - Phoenix
- CCOP - Mayo Clinic Scottsdale Oncology Program - Scottsdale
- Scottsdale Healthcare - Shea - Scottsdale
- Virginia G. Piper Cancer Center at Scottsdale Healthcare - Osborn - Scottsdale
Alabama
- Comprehensive Cancer Center at University of Alabama at Birmingham - Birmingham
- Mobile Infirmary Medical Center - Mobile
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 743 participants |
| Start Date | 2002-07 |
| Est. Completion | 2022-05-20 |
| Phase | Phase 3 |
What the finished NCT00047008 record still lists
NCT00047008 is an interventional study that assigns participants to a tested intervention. The registered 743 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 (188% higher).
The record links to 1 condition, with Head and Neck Cancer appearing as the primary indexed condition, and to 4 interventions - of which cisplatin is the first listed.
NCT00047008 names 20 study sites across 3 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT00047008 about?
NCT00047008 is a clinical study titled "Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Head and Neck Cancer". RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways and combining it with chemotherapy before surgery may kill more tumor cells. It is not yet known which radiation therapy regimen combined with chemotherapy with or without surg...
What is the current status of trial NCT00047008?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 743 participants. The study started on 2002-07. Estimated completion is 2022-05-20.
What conditions does trial NCT00047008 study?
This clinical trial studies the following conditions: Head and Neck Cancer.
What interventions are being tested in trial NCT00047008?
The interventions under investigation include: cisplatin (DRUG), Standard fractionation RT (RADIATION), Accelerated fractionation radiation therapy (RADIATION), Conventional surgery for select patients (PROCEDURE).
Who is sponsoring clinical trial NCT00047008?
This trial is sponsored by Radiation Therapy Oncology Group, which has 144 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00047008 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 NCT00047008's enrollment target sits among peer trials
743 15th of 250 higher than 236 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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