Trial Outcomes & Findings for Prone Breast Irradiation for Pendulous Breasts (NCT NCT00181363)

Results Overview

Quantitatively compare the 3 D dose distribution in the PTV (Planning Target Volume) and normal tissues in prone position versus supine position

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

1 day after treatment planning

Results posted on

2020-01-28

Participant Flow

Participant milestones

Participant milestones
Measure	Mamma Board Mamma board used during radiotherapy
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prone Breast Irradiation for Pendulous Breasts

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=10 Participants Mamma board
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Netherlands	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day after treatment planning

Population: To investigate dose homogeneity and maximum doses, Dmin (minimum Dose), Dmax (maximum Dose) and Dmean (mean Dose) were calculated for prone position versus supine position.

Quantitatively compare the 3 D dose distribution in the PTV (Planning Target Volume) and normal tissues in prone position versus supine position

Outcome measures

Outcome measures
Measure	Prone n=10 Participants Prone position	Supine n=10 Participants Supine position
Dose Homogeneity 1: PTV Dmax (Gy) PTV	53.6 Gy Standard Deviation 0.6	54.8 Gy Standard Deviation 1.4
Dose Homogeneity 1: PTV Dmin (Gy) PTV	9.8 Gy Standard Deviation 6.7	8.2 Gy Standard Deviation 5.6
Dose Homogeneity 1: PTV Dmean (Gy) PTV	48.2 Gy Standard Deviation 1.2	49.8 Gy Standard Deviation 0.8

PRIMARY outcome

Timeframe: 1 day after treatment planning

Population: To investigate dose homogeneity V105% (volume of tissue receiving more than 105% of the prescribed dose) and V107% (volume of tissue receiving more than 107% of the prescribed dose) were calculated for prone position versus supine position.

Quantitatively compare the 3 D dose distribution in the PTV (Planning Target Volume) in prone position versus supine position

Outcome measures

Outcome measures
Measure	Prone n=10 Participants Prone position	Supine n=10 Participants Supine position
Dose Homogeneity 2: V105% and V107% V105% PTV	1.5 cc Standard Deviation 1.2	9.1 cc Standard Deviation 9.9
Dose Homogeneity 2: V105% and V107% V107% PTV	0.1 cc Standard Deviation 0.3	2.8 cc Standard Deviation 4.8

PRIMARY outcome

Timeframe: 1 day after treatment planning

Population: To investigate dose homogeneity V105% (volume of tissue receiving more than 105% of the prescribed dose) and V107% (volume of tissue receiving more than 107% of the prescribed dose) were calculated for prone position versus supine position.

PTV coverage (% of PTV \< 95% of prescribed dose) in prone position versus supine position

Outcome measures

Outcome measures
Measure	Prone n=10 Participants Prone position	Supine n=10 Participants Supine position
Dose Homogeneity 3: V95 % V95%PTV	78.6 cc Standard Deviation 5.6	91.4 cc Standard Deviation 4.1
Dose Homogeneity 3: V95 % V95%CTV	85.0 cc Standard Deviation 4.2	93.3 cc Standard Deviation 4.0

SECONDARY outcome

Timeframe: during treatment planning

Doses in organs at risk: lung MLD (Mean Lung Dose)

Outcome measures

Outcome measures
Measure	Prone n=10 Participants Prone position	Supine n=10 Participants Supine position
PTV Coverage in Organs at Risk: MLD (Gy)	0.9 Gy Standard Deviation 0.6	4.1 Gy Standard Deviation 1.6

SECONDARY outcome

Timeframe: during treatment planning

Doses in organs at risk: heart V30: the volumes (%) of the heart that received \>= 30Gy

Outcome measures

Outcome measures
Measure	Prone n=10 Participants Prone position	Supine n=10 Participants Supine position
PTV Coverage in Organs at Risk: Heart V30	2.4 percentage of V30 Standard Deviation 3.0	7.3 percentage of V30 Standard Deviation 4.6

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

J. Buijsen,

Maastro Radiation Oncology

Phone: +31 (0)88-44-55-666

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place