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NCT00863512 · ClinicalTrials.gov registry record · Phase 3
Chemotherapy or Observation in Treating Patients With Early Stage Non-Small Cell Lung Cancer
A Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.
- Terminated
- Registry status
- Phase 3
- Development phase
- 34
- Enrollment target
NCT00863512: Clinical Trial Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.
NCT00863512 is a Phase 3 study that was terminated before completion, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 34 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00863512, a Phase 3 study, was terminated before completion, sponsored by Alliance for Clinical Trials in Oncology.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 34 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as vinorelbine, cisplatin, docetaxel, gemcitabine, and pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sometimes after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether chemotherapy is more effective than observation in treating patients who have undergone surgery for stage I non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying four chemotherapy regimens to see how well they work compared with observation in treating patients with early stage non-small cell lung cancer.
Primary Outcome
Overall survival (OS) is defined as the time between formal registration and death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.
Interventions
- DRUG cisplatin
- DRUG docetaxel
- DRUG gemcitabine hydrochloride
- DRUG pemetrexed disodium
- DRUG vinorelbine tartrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2009-03 |
| Est. Completion | 2012-11 |
| Phase | Phase 3 |
Why NCT00863512 stopped before completion
NCT00863512 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 5 interventions - of which cisplatin is the first listed.
NCT00863512 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00863512 about?
NCT00863512 is a clinical study titled "Chemotherapy or Observation in Treating Patients With Early Stage Non-Small Cell Lung Cancer". RATIONALE: Drugs used in chemotherapy, such as vinorelbine, cisplatin, docetaxel, gemcitabine, and pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sometimes after surgery, the tumor may not need more treatm...
What is the current status of trial NCT00863512?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 34 participants. The study started on 2009-03. Estimated completion is 2012-11.
What interventions are being tested in trial NCT00863512?
The interventions under investigation include: cisplatin (DRUG), docetaxel (DRUG), gemcitabine hydrochloride (DRUG), pemetrexed disodium (DRUG), vinorelbine tartrate (DRUG).
Who is sponsoring clinical trial NCT00863512?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00863512's enrollment target sits among peer trials
34 1905th of 2000 higher than 94 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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