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NCT00153803 · ClinicalTrials.gov registry record · Phase 3
Erlotinib or Placebo Following Chemoradiotherapy (Chemo/RT) in Stage III Non-Small Cell Lung Cancer (NSCLC)
A Phase 3 study, sponsored by Dartmouth-Hitchcock Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 245
- Enrollment target
NCT00153803 is a Phase 3 study that has completed, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 245 participants.
The verdict
NCT00153803, a Phase 3 study, has completed, sponsored by Dartmouth-Hitchcock Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 245 participants
- Enrollment target
Study Summary
This is a national, randomized, web-based, double-blind study to determine whether erlotinib (Tarceva) compared to placebo improves progression-free survival (PFS) for patients with inoperable, stage III NSCLC following concurrent docetaxel, carboplatin and thoracic radiotherapy. We hypothesize that the introduction of this orally active, well-tolerated agent following concurrent chemoradiation and prior to the emergence of drug resistance will prolong the progression-free survival by 40% (10 months → 14 months).
Interventions
- DRUG Placebo
- DRUG Erlotinib (tarceva)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 245 participants |
| Start Date | 2005-05 |
| Est. Completion | 2014-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00153803
The ClinicalTrials.gov registry entry for NCT00153803 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 245 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dartmouth-Hitchcock Medical Center, which has 427 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00153803 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00153803 about?
NCT00153803 is a clinical study titled "Erlotinib or Placebo Following Chemoradiotherapy (Chemo/RT) in Stage III Non-Small Cell Lung Cancer (NSCLC)". This is a national, randomized, web-based, double-blind study to determine whether erlotinib (Tarceva) compared to placebo improves progression-free survival (PFS) for patients with inoperable, stage III NSCLC following concurrent docetaxel, carboplatin and thoracic radiotherapy. We hypothesize that...
What is the current status of trial NCT00153803?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 245 participants. The study started on 2005-05. Estimated completion is 2014-04.
What interventions are being tested in trial NCT00153803?
The interventions under investigation include: Placebo (DRUG), Erlotinib (tarceva) (DRUG).
Who is sponsoring clinical trial NCT00153803?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
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