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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: Completed Phase 3 study, sponsored by Dartmouth-Hitchcock Medical Center.
NCT00153803 is a Phase 3 study that has completed, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 245 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Progression Free Survival is defined as time from randomization until documented disease progression or death from any cause. The Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.0) was used to determine disease progression. Irradiated target lesions were considered non-measurable disease. Symptomatic radiographic changes of irradiated non-measurable disease required pathologically confirmation or positive FDG-PET scan 6 months following completion of concurrent chemoradiation to
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 |
What the finished NCT00153803 record still lists
NCT00153803 is an interventional study that assigns participants to a tested intervention. The registered 245 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00153803 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00153803's enrollment target sits among peer trials
245 1267th of 2000 higher than 732 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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