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NCT01657617 · ClinicalTrials.gov registry record · NA
Stereotactic Body Radiation Therapy in Stage II/III Non Small Cell Lung Cancer
A NA study of Lung Cancer, sponsored by Ronald McGarry.
- Completed
- Registry status
- NA
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT01657617: Completed NA study of Lung Cancer, sponsored by Ronald McGarry.
NCT01657617 is a NA study of Lung Cancer that has completed, run by Ronald McGarry. The registered enrollment target is 35 participants, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01657617, a NA study of Lung Cancer, has completed, sponsored by Ronald McGarry.
- COMPLETED
- Registry status
- NA
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
It is apparent that local control for Non-small Cell Lung Cancer (NSCLC) remains a significant problem. Conventional radiation therapy techniques have limitations for the dose that can be delivered to a chest tumor mass due to the adjacent dose limiting organs. Mounting evidence supports the use of hypofractionated stereotactically delivered radiation therapy to control lung cancer with acceptable toxicity profiles. Thus the investigators propose to increase the doses of radiation to residual masses of NSCL to a BED \> 100 Gy by the addition of two fractions of stereotactically delivered boost radiation therapy to residual disease post-conventional chemoradiation to at least 59.4 Gy in 180 cGy fractions. Using the linear quadratic equation to model doses of radiation therapy, 59.4 Gy would have a BED of approximately 70 Gy. Single fraction stereotactic body radiation therapy (SBRT) of 10 Gy would have a BED of approximately 20 Gy. Thus the addition of two fractions of 10Gy of SBRT to limited volumes of PET residual disease would theoretically result in higher degrees of local control of lung cancer masses, achieving a minimum cumulative BED of approximately 110Gy-equivalent.
Primary Outcome
Pneumonitis will be used as a marker of lung toxicity as a result of the Boost treatment. Participants will follow up with their treating physician annually for five years after treatment with SBRT . Any incidence of pneumonitis will be documented. Data will be presented as the percent of subjects receiving SBRT that required treatment for pneumonitis.
Conditions Studied
Interventions
- RADIATION Boost Stereotactic Body Radiation Therapy
Study Locations (1)
Kentucky
- Markey Cancer Center - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2007-10-01 |
| Est. Completion | 2018-07-09 |
| Phase | NA |
What the finished NCT01657617 record still lists
NCT01657617 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which Boost Stereotactic Body Radiation Therapy is the first listed.
NCT01657617 reports a single indexed study location in Kentucky.
Frequently Asked Questions
What is clinical trial NCT01657617 about?
NCT01657617 is a clinical study titled "Stereotactic Body Radiation Therapy in Stage II/III Non Small Cell Lung Cancer". It is apparent that local control for Non-small Cell Lung Cancer (NSCLC) remains a significant problem. Conventional radiation therapy techniques have limitations for the dose that can be delivered to a chest tumor mass due to the adjacent dose limiting organs. Mounting evidence supports the use of ...
What is the current status of trial NCT01657617?
This trial is currently completed. It is a NA study. The enrollment target is 35 participants. The study started on 2007-10-01. Estimated completion is 2018-07-09.
What conditions does trial NCT01657617 study?
This clinical trial studies the following conditions: Lung Cancer.
What interventions are being tested in trial NCT01657617?
The interventions under investigation include: Boost Stereotactic Body Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT01657617?
This trial is sponsored by Ronald McGarry, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01657617 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Lung Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01657617's enrollment target sits among peer trials
35 312th of 409 higher than 98 of 409 other Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lung Cancer 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.
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