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NCT01209520 · ClinicalTrials.gov registry record · NA
Residual Hypermethylation in Early Stage Non-Small Cell Lung Cancer (NSCLC) As Part of Adjuvant Therapy and Preventive Strategy
A NA study, sponsored by University of Miami.
- Completed
- Registry status
- NA
- Development phase
- 6
- Enrollment target
NCT01209520: Completed NA study, sponsored by University of Miami.
NCT01209520 is a NA study that has completed, run by University of Miami. The registered enrollment target is 6 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01209520, a NA study, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- NA
- Development phase
- 6 participants
- Enrollment target
Study Summary
The trial investigates the feasibility and efficacy of targeting Non-Small Cell Lung Cancer (NSCLC) "driven" by epigenetic changes. The investigators study the impact of 5-azacitidine (Vidaza®, Celgene, Summit, NJ, USA) in combination with conventional cytotoxic chemotherapy in a sequential fashion. The study population consists of all NSCLC patients who undergo "curative" lung cancer resection and whose tumors harbor hypermethylation in any of the protocol-specific genes (samples will be banked for additional molecular testing including other 21 loci which have shown to be important in lung carcinogenesis.
Primary Outcome
To determine the feasibility and efficacy of incorporating a demethylating agent (5-azacitidine; Vidaza®, Celgene, Summit, NJ, USA) as part of adjuvant therapy in patients diagnosed with NSCLC who harbor methylated tumor supressor genes (TSGs) in their tumor tissue and/or serum. Response to be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.0.
Interventions
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Paclitaxel
- DRUG Vidaza
- PROCEDURE Tumor Specimen for Methylation Analysis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2009-07 |
| Phase | NA |
What the finished NCT01209520 record still lists
NCT01209520 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.
NCT01209520 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01209520 about?
NCT01209520 is a clinical study titled "Residual Hypermethylation in Early Stage Non-Small Cell Lung Cancer (NSCLC) As Part of Adjuvant Therapy and Preventive Strategy". The trial investigates the feasibility and efficacy of targeting Non-Small Cell Lung Cancer (NSCLC) "driven" by epigenetic changes. The investigators study the impact of 5-azacitidine (Vidaza®, Celgene, Summit, NJ, USA) in combination with conventional cytotoxic chemotherapy in a sequential fashion....
What is the current status of trial NCT01209520?
This trial is currently completed. It is a NA study. The enrollment target is 6 participants. The study started on 2009-07.
What interventions are being tested in trial NCT01209520?
The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Paclitaxel (DRUG), Vidaza (DRUG), Tumor Specimen for Methylation Analysis (PROCEDURE).
Who is sponsoring clinical trial NCT01209520?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01209520's enrollment target sits among peer trials
6 1983rd of 2000 higher than 13 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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