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NCT00216125 · ClinicalTrials.gov registry record · Phase 3
Cisplatin/Etoposide/Radiotherapy +/- Consolidation Docetaxel in Advanced Stage III Non-Small Cell Lung Cancer
A Phase 3 study of Non-Small Cell Lung Cancer, sponsored by Nasser Hanna, M.D..
- Completed
- Registry status
- Phase 3
- Development phase
- 243
- Enrollment target
- 15
- Study locations
NCT00216125: Completed Phase 3 study of Non-Small Cell Lung Cancer, sponsored by Nasser Hanna, M.D..
NCT00216125 is a Phase 3 study of Non-Small Cell Lung Cancer that has completed, run by Nasser Hanna, M.D.. The registered enrollment target is 243 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (63% lower). The trial reports 15 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00216125, a Phase 3 study of Non-Small Cell Lung Cancer, has completed, sponsored by Nasser Hanna, M.D..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 243 participants
- Enrollment target
- 15
- Study locations
Study Summary
In a previous phase II study, patients with pathological stage IIIb (without pleural effusion) NSCLC were treated with concurrent cisplatin and etoposide plus thoracic radiotherapy followed by 3 cycles of consolidation therapy with docetaxel. Docetaxel was selected based upon a survival benefit in patients with recurrent NSCLC. This trial will evaluate the role of consolidation therapy with docetaxel in patients with unresectable stage III disease. The purpose of the trial is to evaluate survival and toxicities of the regimens employed.
Primary Outcome
A comparison of overall survival following cisplatin/etoposide/radiotherapy between the consolidation docetaxel and observation arms was analyzed using Kaplan-Meier analysis. Median survival time and a log rank test were used to analyze the hypothesized improvement in overall survival.
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG Cisplatin
- DRUG Etoposide
- RADIATION Radiation
Study Locations (15)
Indiana
- Elkhart Clinic - Elkhart
- Oncology Hematology Associates of SW Indiana - Evansville
- Fort Wayne Oncology & Hematology, Inc - Fort Wayne
- Center for Cancer Care at Goshen Health System - Goshen
- Indiana University Cancer Center - Indianapolis
- Quality Cancer Center (MCGOP) - Indianapolis
- Community Regional Cancer Center - Indianapolis
- Medical Consultants, P.C. - Muncie
- Center for Cancer Care, Inc., P.C. - New Albany
- Northern Indiana Cancer Research Consortium - South Bend
- AP&S Clinic - Terre Haute
Illinois
- Medical & Surgical Specialists, LLC - Galesburg
Missouri
- Siteman Cancer Center - St Louis
Nebraska
- Methodist Cancer Center - Omaha
Texas
- US Oncology - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 243 participants |
| Start Date | 2002-02 |
| Est. Completion | 2008-03 |
| Phase | Phase 3 |
What the finished NCT00216125 record still lists
NCT00216125 is an interventional study that assigns participants to a tested intervention. The registered 243 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (63% lower).
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 4 interventions - of which Docetaxel is the first listed.
NCT00216125 lists 15 locations in 5 states (Indiana, Illinois, Missouri).
Frequently Asked Questions
What is clinical trial NCT00216125 about?
NCT00216125 is a clinical study titled "Cisplatin/Etoposide/Radiotherapy +/- Consolidation Docetaxel in Advanced Stage III Non-Small Cell Lung Cancer". In a previous phase II study, patients with pathological stage IIIb (without pleural effusion) NSCLC were treated with concurrent cisplatin and etoposide plus thoracic radiotherapy followed by 3 cycles of consolidation therapy with docetaxel. Docetaxel was selected based upon a survival benefit in p...
What is the current status of trial NCT00216125?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 243 participants. The study started on 2002-02. Estimated completion is 2008-03.
What conditions does trial NCT00216125 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT00216125?
The interventions under investigation include: Docetaxel (DRUG), Cisplatin (DRUG), Etoposide (DRUG), Radiation (RADIATION).
Who is sponsoring clinical trial NCT00216125?
This trial is sponsored by Nasser Hanna, M.D., which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00216125 being conducted?
This trial has 15 study locations across Illinois, Indiana, Missouri, Nebraska, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT00216125's enrollment target sits among peer trials
243 151st of 454 higher than 303 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung 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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