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NCT00499109 · ClinicalTrials.gov registry record · Phase 3
Phase III of RRM1 & ERCC1 Directed Customized Chemotherapy for the Treatment of Patients With NSCLC
A Phase 3 study of Non-Small Cell Lung Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 3
- Development phase
- 275
- Enrollment target
- 9
- Study locations
NCT00499109 is a Phase 3 study of Non-Small Cell Lung Cancer that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 275 participants, below the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (58% lower). The trial reports 9 study locations across 6 states.
The verdict
NCT00499109, a Phase 3 study of Non-Small Cell Lung Cancer, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 275 participants
- Enrollment target
- 9
- Study locations
Study Summary
This is a clinical research study to evaluate if chemotherapy in the experimental arm (E) results in a better outcome compared to patients in the standard of care arm (C). 2:1 randomization to experimental arm (E) or standard arm (C). In arm E, treatment of dual-agent chemotherapy will be selected based on RRM1 and ERCC1 expression at the protein level. In arm C, treatment of dual-agent chemotherapy will be gemcitabine/carboplatin, i.e., standard of care.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Docetaxel
- DRUG Gemcitabine
- DRUG Vinorelbine
Study Locations (9)
Florida
- Center for Cancer Care & Research/Watson - Lakeland
- Leesburg Regional Medical Center - Leesburg
- H. Lee Moffitt Cancer Center & Research Institute - Tampa
Other
- Klinik Loewenstein - Löwenstein
- Ponce School of Medicine - Ponce
Maryland
- Johns Hopkins Sidney Kimmell Comprehensive Cancer Center - Baltimore
Michigan
- Barbara Ann Karmanos Cancer Institute - Detroit
Nebraska
- Southeast Nebraska Cancer Center - Lincoln
Pennsylvania
- Fox Chase Cancer Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 275 participants |
| Start Date | 2007-05 |
| Est. Completion | 2013-11 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00499109
The ClinicalTrials.gov registry entry for NCT00499109 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 275 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (58% lower). The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 4 interventions - of which Carboplatin is the first listed.
NCT00499109 reports 9 study locations spanning 6 distinct geographic areas - top geographies include Florida, Other, Maryland.
Frequently Asked Questions
What is clinical trial NCT00499109 about?
NCT00499109 is a clinical study titled "Phase III of RRM1 & ERCC1 Directed Customized Chemotherapy for the Treatment of Patients With NSCLC". This is a clinical research study to evaluate if chemotherapy in the experimental arm (E) results in a better outcome compared to patients in the standard of care arm (C). 2:1 randomization to experimental arm (E) or standard arm (C). In arm E, treatment of dual-agent chemotherapy will be selected ...
What is the current status of trial NCT00499109?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 275 participants. The study started on 2007-05. Estimated completion is 2013-11.
What conditions does trial NCT00499109 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT00499109?
The interventions under investigation include: Carboplatin (DRUG), Docetaxel (DRUG), Gemcitabine (DRUG), Vinorelbine (DRUG).
Who is sponsoring clinical trial NCT00499109?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00499109 being conducted?
This trial has 9 study locations across Florida, Maryland, Michigan, Nebraska, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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