Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00545948 · ClinicalTrials.gov registry record · Phase 2
Adjuvant Cisplatin With Either Genomic-Guided Vinorelbine or Pemetrexed for Early Stage Non-Small-Cell Lung Cancer
A Phase 2 study, sponsored by Duke University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
NCT00545948 is a Phase 2 study that was terminated before completion, run by Duke University. The registered enrollment target is 31 participants.
The verdict
NCT00545948, a Phase 2 study, was terminated before completion, sponsored by Duke University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
Study Summary
This study assigned subjects to either cisplatin/vinorelbine or cisplatin/pemetrexed chemotherapy using a genomic based expression profile to determine chemotherapy sensitivity in completely resected early stage non-squamous non-small-cell lung cancer (NSCLC). The vinorelbine-sensitive tumors group received Vinorelbine followed by cisplatin, while the pemetrexed-sensitive tumors group received pemetrexed followed by cisplatin. The primary objective of this trial was to determine whether genomic-based adjuvant chemotherapy treatment increased the 2-year progression-free survival rate in completely resected patients with NSCLC compared to historic controls. Secondary objectives included: 1) estimation of the percentage of completely resected NSCLC tumors that can be adequately analyzed and used to direct specific adjuvant chemotherapy; 2) estimation of the proportion of patients who are assigned to treatment with vinorelbine and pemetrexed; 3) evaluation of drug sensitivity patterns of cisplatin and pemetrexed in both treatment arms; 4) description of the overall median survival experience of treated patients; and 5) assessment of patient understanding and perceptions of participating in a clinical trial evaluating cancer genomics for adjuvant treatment of early stage lung cancer.
Interventions
- DRUG Vinorelbine followed by Cisplatin
- DRUG Pemetrexed followed by Cisplatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2007-12 |
| Est. Completion | 2012-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00545948
The ClinicalTrials.gov registry entry for NCT00545948 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Vinorelbine followed by Cisplatin is the first listed.
NCT00545948 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00545948 about?
NCT00545948 is a clinical study titled "Adjuvant Cisplatin With Either Genomic-Guided Vinorelbine or Pemetrexed for Early Stage Non-Small-Cell Lung Cancer". This study assigned subjects to either cisplatin/vinorelbine or cisplatin/pemetrexed chemotherapy using a genomic based expression profile to determine chemotherapy sensitivity in completely resected early stage non-squamous non-small-cell lung cancer (NSCLC). The vinorelbine-sensitive tumors group ...
What is the current status of trial NCT00545948?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2007-12. Estimated completion is 2012-01.
What interventions are being tested in trial NCT00545948?
The interventions under investigation include: Vinorelbine followed by Cisplatin (DRUG), Pemetrexed followed by Cisplatin (DRUG).
Who is sponsoring clinical trial NCT00545948?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.