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| Name | Class |
|---|---|
| Maastricht University | OTHER |
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We hypothesize that for large pendulous breasts, breast irradiation in supine and prone position are equivalent with regard to coverage of the PTV, but with a better dose homogeneity in prone position and a smaller radiation exposure of lung and heart.The purpose of this study is to compare the 3-D dose distribution in PTV(Planning Target Volume) and normal tissues in prone position versus supine position.
Local excision followed by adjuvant radiotherapy has become standard treatment for women with early-stage breast cancer. Adjuvant radiotherapy may encounter technical difficulties in patients with pendulous breasts when treated in supine position.
Based upon literature and our own preliminary experiences, we hypothesize that for large pendulous breasts, breast irradiation in supine and prone position are equivalent with regard to coverage of the PTV, but with a better dose homogeneity in prone position and a smaller radiation exposure of lung and heart. However, no quantitative data are yet available to test this hypothesis. Therefore, the aim of our study is to compare the 3-D dose distribution in PTV and normal tissues in prone position versus supine position. For treatment in prone-position an in-house developed device, the "mammaboard" was used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mamma board | Experimental | use of the mamma board during radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mamma board | Device | use of mamma board during radiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Homogeneity 1: PTV | Quantitatively compare the 3 D dose distribution in the PTV (Planning Target Volume) and normal tissues in prone position versus supine position | 1 day after treatment planning |
| Dose Homogeneity 2: V105% and V107% | Quantitatively compare the 3 D dose distribution in the PTV (Planning Target Volume) in prone position versus supine position | 1 day after treatment planning |
| Dose Homogeneity 3: V95 % | PTV coverage (% of PTV < 95% of prescribed dose) in prone position versus supine position | 1 day after treatment planning |
| Measure | Description | Time Frame |
|---|---|---|
| PTV Coverage in Organs at Risk: MLD (Gy) | Doses in organs at risk: lung MLD (Mean Lung Dose) | during treatment planning |
| PTV Coverage in Organs at Risk: Heart V30 | Doses in organs at risk: heart V30: the volumes (%) of the heart that received >= 30Gy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeroen Buijsen, MD | Maastricht Radiation Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht Radiation Oncology | Heerlen | Limburg | 6419 PC | Netherlands |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mamma Board | Mamma board used during radiotherapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Mamma board |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Dose Homogeneity 1: PTV | Quantitatively compare the 3 D dose distribution in the PTV (Planning Target Volume) and normal tissues in prone position versus supine position | 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. | Posted | Mean | Standard Deviation | Gy | 1 day after treatment planning |
|
during treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | Mamma board |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| J. Buijsen, | Maastro Radiation Oncology | +31 (0)88-44-55-666 | jeroen.buijsen@maastro.nl |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| during treatment planning |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Dose Homogeneity 2: V105% and V107% | Quantitatively compare the 3 D dose distribution in the PTV (Planning Target Volume) in prone position versus supine position | 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. | Posted | Mean | Standard Deviation | cc | 1 day after treatment planning |
|
|
|
|
| Secondary | PTV Coverage in Organs at Risk: MLD (Gy) | Doses in organs at risk: lung MLD (Mean Lung Dose) | Posted | Mean | Standard Deviation | Gy | during treatment planning |
|
|
|
|
| Secondary | PTV Coverage in Organs at Risk: Heart V30 | Doses in organs at risk: heart V30: the volumes (%) of the heart that received >= 30Gy | Posted | Mean | Standard Deviation | percentage of V30 | during treatment planning |
|
|
|
|
| Primary | Dose Homogeneity 3: V95 % | PTV coverage (% of PTV < 95% of prescribed dose) in prone position versus supine position | 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. | Posted | Mean | Standard Deviation | cc | 1 day after treatment planning |
|
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|
|
| 0 |
| 10 |
| 0 |
| 10 |
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| D017437 |
| Skin and Connective Tissue Diseases |