Breast CancerNCT00181363
Prone Breast Irradiation for Pendulous Breasts
A study testing Mamma board in people with Breast Cancer, run by Maastricht Radiation Oncology at 1 site in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Mamma board
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2003to Jan 2007
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients should have had breast-conserving surgery for breast cancer or DCIS (Ductal Carcinoma in Situ)
- No indication for radiotherapy of regional nodes
- Large, pendulous breasts (bra size D and over)
Who cannot join
- Regional radiotherapy is indicated
- Unable to lie in prone position
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mamma Board Project: Prone Breast Irradiation for Pendulous Breasts
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.
Read the detailed description
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.
- Conditions
- Breast Cancer
- Being tested
- Mamma board
- Keywords
- Breast cancer, Breast conserving surgery, Radiotherapy, Pendulous breasts
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mamma boardDevice
Also called radiation, prone breast, mammaboard
use of mamma board during radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Mamma board | Experimental | use of the mamma board during radiotherapy Receives: Device: Mamma board |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1 day after treatment planning
Dose Homogeneity 3: V95 %
PTV coverage (% of PTV < 95% of prescribed dose) in prone position versus supine position
Measured: 1 day after treatment planning
Secondary outcomes (2)
PTV Coverage in Organs at Risk: MLD (Gy)
Doses in organs at risk: lung MLD (Mean Lung Dose)
Measured: 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
Measured: during treatment planning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startDec 2003
- Primary completionJul 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University
- Responsible party
- Sponsor
- Investigators
- Jeroen Buijsen, MD, Principal investigator, Maastricht Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00181363
- Sponsor's protocol ID
- P03.1446L
- Status last verified
- Jan 2020
- First submitted
- 9 Sep 2005
- Last updated
- 28 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mamma Board Project: Prone Breast Irradiation for Pendulous Breasts
- ClinicalTrials.gov ID
- NCT00181363
- Acronym / sponsor ID
- P03.1446L
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Breast conserving surgery, Radiotherapy, Pendulous breasts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Collaborators
- Maastricht University
- Study start
- Dec 2003
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Posted 28 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mamma board | Experimental | Device: Mamma boarduse of the mamma board during radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients should have had breast-conserving surgery for breast cancer or DCIS (Ductal Carcinoma in Situ)
- No indication for radiotherapy of regional nodes
- Large, pendulous breasts (bra size D and over)
Key exclusion criteria (2 listed)
- Regional radiotherapy is indicated
- Unable to lie in prone position
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mamma boardAlso: radiation, prone breast, mammaboarduse of mamma board during radiotherapy | Device | Mamma board |
Primary outcome
Dose Homogeneity 1: PTV
Time frame: 1 day after treatment planning
Quantitatively compare the 3 D dose distribution in the PTV (Planning Target Volume) and normal tissues in prone position versus supine position
Dose Homogeneity 2: V105% and V107%
Time frame: 1 day after treatment planning
Quantitatively compare the 3 D dose distribution in the PTV (Planning Target Volume) in prone position versus supine position
Dose Homogeneity 3: V95 %
Time frame: 1 day after treatment planning
PTV coverage (% of PTV < 95% of prescribed dose) in prone position versus supine position
2 secondary outcomes
PTV Coverage in Organs at Risk: MLD (Gy)
Time frame: during treatment planning
PTV Coverage in Organs at Risk: Heart V30
Time frame: during treatment planning
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeroen Buijsen, MD principal investigator
Maastricht Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mamma board in people with Breast Cancer, run by Maastricht Radiation Oncology at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Homogeneity 1: PTV (time frame: 1 day after treatment planning). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.