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NCT01797471 · ClinicalTrials.gov registry record · NA
Safety of LEAD Radiotherapy Plus Chemoradiation in Patients With Bulky Stage III Non-Small Cell Lung Cancer
A NA study, sponsored by University of Miami.
- Terminated
- Registry status
- NA
- Development phase
- 1
- Enrollment target
NCT01797471: Clinical Trial NA study, sponsored by University of Miami.
NCT01797471 is a NA study that was terminated before completion, run by University of Miami. The registered enrollment target is 1 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
NCT01797471, a NA study, was terminated before completion, sponsored by University of Miami.
- TERMINATED
- Registry status
- NA
- Development phase
- 1 participants
- Enrollment target
Study Summary
The investigators aim to evaluate the safety of delivering a one-time single fraction of Lattice Extreme Ablative Dose (LEAD) radiotherapy followed one day later by standard-dose, conventionally fractionated concurrent chemotherapy and radiation delivered over 6 weeks in patients with bulky stage III non-small cell lung cancer in the setting of a single-arm phase I clinical trial. The investigators hypothesize that the addition of a one-time single fraction of LEAD radiation is safe and feasible, and will not result in additional toxicity above that expected with standard-dose concurrent chemotherapy and radiation alone.
Primary Outcome
Rate of treatment-related toxicity (serious adverse events, adverse events, etc.) in study participants. Toxicity will be assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The two toxicities that will be monitored as primary endpoints are esophagitis and pneumonitis.
Interventions
- RADIATION Lattice Extreme Ablative Dose (LEAD) Radiation Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2013-03 |
| Est. Completion | 2013-11-06 |
| Phase | NA |
Why NCT01797471 stopped before completion
NCT01797471 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 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 1 intervention - of which Lattice Extreme Ablative Dose (LEAD) Radiation Therapy is the first listed.
NCT01797471 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01797471 about?
NCT01797471 is a clinical study titled "Safety of LEAD Radiotherapy Plus Chemoradiation in Patients With Bulky Stage III Non-Small Cell Lung Cancer". The investigators aim to evaluate the safety of delivering a one-time single fraction of Lattice Extreme Ablative Dose (LEAD) radiotherapy followed one day later by standard-dose, conventionally fractionated concurrent chemotherapy and radiation delivered over 6 weeks in patients with bulky stage II...
What is the current status of trial NCT01797471?
This trial is currently terminated. It is a NA study. The enrollment target is 1 participants. The study started on 2013-03. Estimated completion is 2013-11-06.
What interventions are being tested in trial NCT01797471?
The interventions under investigation include: Lattice Extreme Ablative Dose (LEAD) Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT01797471?
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 NCT01797471's enrollment target sits among peer trials
1 2001st of 2000 the lowest 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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