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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: Completed Phase 3 study of Non-Small Cell Lung Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
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 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (58% lower). The trial reports 9 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. The data of first documented disease progression or death, as defined by Response Evaluation Criteria In Solid Tumors (RECIST), was recorded, and the time interval from randomization to that date was calculated for each patient and used to generate Kapl
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 |
What the finished NCT00499109 record still lists
NCT00499109 is an interventional study that assigns participants to a tested intervention. The registered 275 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 (58% 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 Carboplatin is the first listed.
NCT00499109 lists 9 locations in 6 states (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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Where NCT00499109's enrollment target sits among peer trials
275 137th of 454 higher than 318 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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