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NCT00229723 · ClinicalTrials.gov registry record · Phase 2
IRESSA™ (Gefitinib) With Cisplatin Plus Radiotherapy for the Treatment of Previously Untreated Unresected Late Stage III/IV Non-Metastatic Head and Neck Squamous Cell Carcinoma
A Phase 2 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 2
- Development phase
- 224
- Enrollment target
NCT00229723: Completed Phase 2 study, sponsored by AstraZeneca.
NCT00229723 is a Phase 2 study that has completed, run by AstraZeneca. The registered enrollment target is 224 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00229723, a Phase 2 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 224 participants
- Enrollment target
Study Summary
The primary purpose of this study is to assess the effectiveness of ZD1839 250 mg and 500 mg when given either concomitantly or as maintenance to a standard therapy of radiotherapy (X-rays) plus chemotherapy (cisplatin) in terms of local disease control (progression-free) rate at 2 years.
Primary Outcome
A patient demonstrated local disease control at 2 years if there was no evidence of failure of treatment. Failure was defined as the patient having objective disease progression (as per RECIST) inside the original irradiated area, at an isodose level (between 20% and 95%), or death.
Interventions
- DRUG cisplatin
- RADIATION radiotherapy
- DRUG gefitinib (Iressa)
- DRUG Gefitinib (Iressa)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 224 participants |
| Start Date | 2004-11 |
| Est. Completion | 2008-06 |
| Phase | Phase 2 |
What the finished NCT00229723 record still lists
NCT00229723 is an interventional study that assigns participants to a tested intervention. The registered 224 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% higher).
The record links to 0 conditions, and to 4 interventions - of which cisplatin is the first listed.
NCT00229723 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00229723 about?
NCT00229723 is a clinical study titled "IRESSA™ (Gefitinib) With Cisplatin Plus Radiotherapy for the Treatment of Previously Untreated Unresected Late Stage III/IV Non-Metastatic Head and Neck Squamous Cell Carcinoma". The primary purpose of this study is to assess the effectiveness of ZD1839 250 mg and 500 mg when given either concomitantly or as maintenance to a standard therapy of radiotherapy (X-rays) plus chemotherapy (cisplatin) in terms of local disease control (progression-free) rate at 2 years.
What is the current status of trial NCT00229723?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 224 participants. The study started on 2004-11. Estimated completion is 2008-06.
What interventions are being tested in trial NCT00229723?
The interventions under investigation include: cisplatin (DRUG), radiotherapy (RADIATION), gefitinib (Iressa) (DRUG), Gefitinib (Iressa) (DRUG).
Who is sponsoring clinical trial NCT00229723?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00229723's enrollment target sits among peer trials
224 269th of 2000 higher than 1,727 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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