CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 35 enrolled
Drug / intervention
Boost Stereotactic Body Radiation Therapyradiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01657617
NCT01657617N/ACompleted

Stereotactic Body Radiation Therapy for Post-chemoradiation Residual Disease in Stage II/III Non-small Cell Lung Cancer

Ronald McGarry·interventional·Posted Aug 6, 2012·Updated Oct 5, 2018

In Brief

A clinical study evaluating Boost Stereotactic Body Radiation Therapy for Lung Cancer. Completed, enrolled 35 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 6, 2012
Enrollment StartOct 1, 2007
Primary CompletionJun 5, 2014
Study CompletionJul 9, 2018
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 13.9 years ago

Interventions

Boost Stereotactic Body Radiation Therapyradiation

The dose and fractionation scheme utilized will be based on the location of the patient's residual disease. For patients with: Peripheral Tumors: Treatment will consist of 2 fractions of radiation, with a minimum of 40 hours separating each fraction. Two fractions of 10 Gy with inhomogeneity correction will be delivered to the prescription line at the edge of the PTV for a total of 20 Gy. This will yield a total BED of 110 Gy. Medial Tumors: Treatment will consist of 3 fractions of radiation, with a minimum of 40 hours separating each fraction. Three fractions of 6.5 Gy with inhomogeneity correction will be delivered to the prescription line at the edge of the PTV for a total of 19.5 Gy. This will yield a total BED 102.2 Gy.