NCT01586104 · OUTCOME

Mean Percentage Radiation Dose to Organ Volumes

Intensity-Modulated Radiation Therapy in Treating Younger Patients With Lung Metastases · Source last updated 2025-02-10

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEAN
Unit: Mean % radiation dose to % organ volume
Interval / dispersion: Standard Deviation
Time frame: This outcome is measured from central review of radiation plans within 1-2 days of receipt.

What was measured

The IMRT and standard anteroposterior (AP-PA) treatment plans were reviewed and compared for target coverage and organ dose-volume histograms. The mean percentage volume of the organ or organ sub-region receiving a percentage of the dose was estimated from the computerized treatment plans for these two techniques were estimated and compared statistically

Groups in this outcome

Treatment (IMRT)

Patients undergo cardiac-sparing whole lung intensity-modulated radiation therapy (IMRT).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Treatment (IMRT)	20

Reported measurements

Heart - V50 (%) for IMRT

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	96	5.4	Not reported	Not reported	Not reported

Heart - V50 (%) for AP- PA

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	100	0.8	Not reported	Not reported	Not reported

Heart - V83 (%) for IMRT

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	65	12.1	Not reported	Not reported	Not reported

Heart - V83 (%) for AP-PA

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	100	2.2	Not reported	Not reported	Not reported

Heart - V95 (%) for IMRT

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	39	15.5	Not reported	Not reported	Not reported

Heart- V95 (%) for AP-PA

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	97	6.7	Not reported	Not reported	Not reported

Left Ventricle - V50 (%) for IMRT

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	95	7.8	Not reported	Not reported	Not reported

Left Ventricle - V50 (%) for AP-PA

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	100	0	Not reported	Not reported	Not reported

Left Ventricle - V95 (%) for IMRT

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	33	15.9	Not reported	Not reported	Not reported

Left Ventricle - V95 (%) for AP-PA

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	99	2.7	Not reported	Not reported	Not reported

Right Ventricle - V50 (%) for IMRT

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	91	9.8	Not reported	Not reported	Not reported

Right Ventricle - V50 (%) for AP-PA

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	100	1.6	Not reported	Not reported	Not reported

Right Ventricle - V83 (%) for IMRT

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	42	12.7	Not reported	Not reported	Not reported

Right Ventricle - V83 (%) for AP-PA

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	99	4	Not reported	Not reported	Not reported

Right Ventricle - V95 (%) for IMRT

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	18	8.9	Not reported	Not reported	Not reported

Right Ventricle - V95 (%) for AP-PA

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	97	8.2	Not reported	Not reported	Not reported

Right Atrium - V50 (%) for IMRT

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	99	0.4	Not reported	Not reported	Not reported

Right Atrium - V50 (%) for AP-PA

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	99	0.7	Not reported	Not reported	Not reported

Right Atrium - V95 (%) for IMRT

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	57	22.5	Not reported	Not reported	Not reported

Right Atrium - V95 (%) for AP-PA

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	97	11.1	Not reported	Not reported	Not reported

Left Atrium V50 (%) for IMRT

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	99	0.4	Not reported	Not reported	Not reported

Left Atrium V50 (%) for AP-PA

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	100	0.2	Not reported	Not reported	Not reported

Left Atrium - V95 (%) for IMRT

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	55	22.3	Not reported	Not reported	Not reported

Left Atrium - V95 (%) for AP-PA

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	94	15.4	Not reported	Not reported	Not reported

Right Coronary Artery - V95 (%) for IMRT

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	100	0	Not reported	Not reported	Not reported

Right Coronary Artery - V95 (%) for AP-PA

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	100	0	Not reported	Not reported	Not reported

Left Coronary Artery - V95 (%) for IMRT

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	88	9.9	Not reported	Not reported	Not reported

Left Coronary Artery - V95 (%) for AP-PA

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	99	1.3	Not reported	Not reported	Not reported

Myocardium - V50 (%) for IMRT

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	94	8	Not reported	Not reported	Not reported

Myocardium - V50 (%) for AP-PA

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	100	0	Not reported	Not reported	Not reported

Myocardium - V95 (%) for IMRT

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	69	7.56	Not reported	Not reported	Not reported

Myocardium - V95 (%) for AP-PA

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	99	0.88	Not reported	Not reported	Not reported

Thyroid - V50 (%) for IMRT

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	44	32.5	Not reported	Not reported	Not reported

Thyroid - V50 (%) for AP-PA

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	33	31.3	Not reported	Not reported	Not reported

Kidneys - V50 (%) for IMRT

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	5	7.6	Not reported	Not reported	Not reported

Kidneys - V50 (%) for AP-PA

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	6	6.8	Not reported	Not reported	Not reported

Stomach - V50 (%) for IMRT

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	62	21.7	Not reported	Not reported	Not reported

Stomach - V50 (%) for AP-PA

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	62	24.5	Not reported	Not reported	Not reported

Liver - V50 (%) for IMRT

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	55	11.4	Not reported	Not reported	Not reported

Liver - V50 (%) for AP-PA

Values in Mean % radiation dose to % organ volume · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Treatment (IMRT)	54	11.4	Not reported	Not reported	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

group Description
Feasibility will be defined as an enrolled patient receiving the IMRT treatment as planned. It is expected that the treatment will be feasible in at least 90% of patients. If the treatment is feasible in 16 or more out of 20 patients, then the treatment will be declared feasible. If the true feasibility rate is 90%, then there is a 4.3% chance that 15 or fewer feasible patients will be observed.
group Ids
OG000
non Inferiority Comment
With 20 patients, there is 80% power to detect a difference of 100% with Standard lung RT versus 93% with IMRT assuming a standard deviation of 8 (as seen for the whole heart), a one tailed test and a Bonferroni correction for 4 statistical tests so that each test is done at p\<0.0125.
non Inferiority Type
OTHER
other Analysis Description
Lung-metastases-free survival will be estimated using Kaplan-Meier survival curves (minimum period of six months).
p Value
<0.0125
p Value Comment
The reported p value was calculated. The statistical analysis performed is attached to the outcome measure reported.
statistical Method
Bonferroni corrected at p<0.0125

Complete source fields

analyses

group Description
Feasibility will be defined as an enrolled patient receiving the IMRT treatment as planned. It is expected that the treatment will be feasible in at least 90% of patients. If the treatment is feasible in 16 or more out of 20 patients, then the treatment will be declared feasible. If the true feasibility rate is 90%, then there is a 4.3% chance that 15 or fewer feasible patients will be observed.
group Ids
OG000
non Inferiority Comment
With 20 patients, there is 80% power to detect a difference of 100% with Standard lung RT versus 93% with IMRT assuming a standard deviation of 8 (as seen for the whole heart), a one tailed test and a Bonferroni correction for 4 statistical tests so that each test is done at p\<0.0125.
non Inferiority Type
OTHER
other Analysis Description
Lung-metastases-free survival will be estimated using Kaplan-Meier survival curves (minimum period of six months).
p Value
<0.0125
p Value Comment
The reported p value was calculated. The statistical analysis performed is attached to the outcome measure reported.
statistical Method
Bonferroni corrected at p<0.0125

classes

categories
measurements
group Id
OG000
spread
5.4
value
96
title
Heart - V50 (%) for IMRT
categories
measurements
group Id
OG000
spread
0.8
value
100
title
Heart - V50 (%) for AP- PA
categories
measurements
group Id
OG000
spread
12.1
value
65
title
Heart - V83 (%) for IMRT
categories
measurements
group Id
OG000
spread
2.2
value
100
title
Heart - V83 (%) for AP-PA
categories
measurements
group Id
OG000
spread
15.5
value
39
title
Heart - V95 (%) for IMRT
categories
measurements
group Id
OG000
spread
6.7
value
97
title
Heart- V95 (%) for AP-PA
categories
measurements
group Id
OG000
spread
7.8
value
95
title
Left Ventricle - V50 (%) for IMRT
categories
measurements
group Id
OG000
spread
0
value
100
title
Left Ventricle - V50 (%) for AP-PA
categories
measurements
group Id
OG000
spread
15.9
value
33
title
Left Ventricle - V95 (%) for IMRT
categories
measurements
group Id
OG000
spread
2.7
value
99
title
Left Ventricle - V95 (%) for AP-PA
categories
measurements
group Id
OG000
spread
9.8
value
91
title
Right Ventricle - V50 (%) for IMRT
categories
measurements
group Id
OG000
spread
1.6
value
100
title
Right Ventricle - V50 (%) for AP-PA

denoms

counts
group Id
OG000
value
20
units
Participants

description

dispersion Type

Standard Deviation

groups

description
Patients undergo cardiac-sparing whole lung intensity-modulated radiation therapy (IMRT).
id
OG000
title
Treatment (IMRT)

param Type

MEAN

reporting Status

POSTED

time Frame

This outcome is measured from central review of radiation plans within 1-2 days of receipt.

title

Mean Percentage Radiation Dose to Organ Volumes

type

SECONDARY

unit Of Measure

Mean % radiation dose to % organ volume

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Preserved source evidence · Not medical advice