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NCT00005838 · ClinicalTrials.gov registry record · Phase 3
Combination Chemotherapy Plus Radiation Therapy With or Without AE-941 in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery
A Phase 3 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 756
- Enrollment target
NCT00005838: Completed Phase 3 study, sponsored by National Cancer Institute (NCI).
NCT00005838 is a Phase 3 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 756 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00005838, a Phase 3 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 756 participants
- Enrollment target
Study Summary
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. AE-941 may help shrink or slow the growth of non-small cell lung cancer cells. It is not yet known if combination chemotherapy plus radiation therapy is more effective with or without AE-941 for non-small cell lung cancer. This randomized phase III trial is studying combination chemotherapy and radiation therapy given with AE-941 to see how well they work compared to combination chemotherapy and radiation therapy alone in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery
Primary Outcome
Survival distributions will be compared by use of the log-rank test. The stratified log-rank test (nominal or categorical covariates) may be used to simultaneously control for important prognostic factors. Kaplan-Meier curves will also be plotted to illustrate the comparative survival experience of both groups over the entire study period.
Interventions
- OTHER placebo
- DRUG cisplatin
- DRUG carboplatin
- DRUG vinorelbine tartrate
- DRUG shark cartilage extract AE-941
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 756 participants |
| Start Date | 2000-03 |
| Phase | Phase 3 |
What the finished NCT00005838 record still lists
NCT00005838 is an interventional study that assigns participants to a tested intervention. The registered 756 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which placebo is the first listed.
NCT00005838 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00005838 about?
NCT00005838 is a clinical study titled "Combination Chemotherapy Plus Radiation Therapy With or Without AE-941 in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery". Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. AE-941 may help shrink or slow the growth of non-small cell lung cance...
What is the current status of trial NCT00005838?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 756 participants. The study started on 2000-03.
What interventions are being tested in trial NCT00005838?
The interventions under investigation include: placebo (OTHER), cisplatin (DRUG), carboplatin (DRUG), vinorelbine tartrate (DRUG), shark cartilage extract AE-941 (DRUG).
Who is sponsoring clinical trial NCT00005838?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00005838's enrollment target sits among peer trials
756 457th of 2000 higher than 1,542 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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