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NCT00095875 · ClinicalTrials.gov registry record · Phase 3
Combination Chemotherapy and Radiation in Treating Patients With Stage III or IV Head and Neck Cancer (Paradigm Trial)
A Phase 3 study of Head and Neck Cancer, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 3
- Development phase
- 145
- Enrollment target
- 15
- Study locations
NCT00095875: Completed Phase 3 study of Head and Neck Cancer, sponsored by Dana-Farber Cancer Institute.
NCT00095875 is a Phase 3 study of Head and Neck Cancer that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 145 participants, below the 260-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (44% lower). The trial reports 15 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00095875, a Phase 3 study of Head and Neck Cancer, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 145 participants
- Enrollment target
- 15
- Study locations
Study Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, fluorouracil, and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet known which regimen of chemotherapy and radiation therapy is most effective in treating head and neck cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of chemotherapy and radiation therapy in treating patients who have stage III or stage IV head and neck cancer.
Primary Outcome
To compare the 3-year survival achieved by docetaxel/cisplatin/5-FU based sequential therapy with platinum based chemo radiotherapy in patients with locally advanced SCCHN. Overall survival is defined as the time from date of randomisation to death from any cause. Patients alive at the time of current analysis were censored at the date last known to be alive.Kaplan-Meier method was used to estimate overall survival
Conditions Studied
Interventions
- DRUG cisplatin
- DRUG carboplatin
- DRUG docetaxel
- DRUG fluorouracil
Study Locations (15)
California
- Rebecca and John Moores UCSD Cancer Center - La Jolla
Colorado
- CCOP - Colorado Cancer Research Program - Denver
Florida
- Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus - Boca Raton
Georgia
- Winship Cancer Institute of Emory University - Atlanta
Illinois
- Cardinal Bernardin Cancer Center at Loyola University Medical Center - Maywood
Maine
- Maine Center for Cancer Medicine and Blood Disorders - Scarborough - Scarborough
Maryland
- Greenebaum Cancer Center at University of Maryland Medical Center - Baltimore
Massachusetts
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 145 participants |
| Start Date | 2004-08 |
| Est. Completion | 2012-04 |
| Phase | Phase 3 |
What the finished NCT00095875 record still lists
NCT00095875 is an interventional study that assigns participants to a tested intervention. The registered 145 participants enrollment target is mid-sized for trials with a published cap, below the 260-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (44% lower).
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.
NCT00095875 lists 15 locations in 15 states (California, Colorado, Florida).
Frequently Asked Questions
What is clinical trial NCT00095875 about?
NCT00095875 is a clinical study titled "Combination Chemotherapy and Radiation in Treating Patients With Stage III or IV Head and Neck Cancer (Paradigm Trial)". RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, fluorouracil, and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may...
What is the current status of trial NCT00095875?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 145 participants. The study started on 2004-08. Estimated completion is 2012-04.
What conditions does trial NCT00095875 study?
This clinical trial studies the following conditions: Head and Neck Cancer.
What interventions are being tested in trial NCT00095875?
The interventions under investigation include: cisplatin (DRUG), carboplatin (DRUG), docetaxel (DRUG), fluorouracil (DRUG).
Who is sponsoring clinical trial NCT00095875?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00095875 being conducted?
This trial has 15 study locations across California, Colorado, Florida, Georgia, Illinois. 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 NCT00095875's enrollment target sits among peer trials
145 65th of 250 higher than 186 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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