Breast CarcinomaNCT00887523
Trial Comparing Prone and Supine Intensity-modulated Radiotherapy (IMRT) After Breast-conserving Surgery in Patients With Large Breast Volume at High Risk for Skin Toxicity and Fibrosis
A study testing radiation in prone position and radiation in supine position in people with Breast Carcinoma, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
84 patients with a cup size C or more will be randomized to receive intensity-modulated radiotherapy in supine or prone position. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- radiation in prone position and radiation in supine position
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2009to 8 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- female patients
- multidisciplinary decision of adjuvant whole-breast irradiation (WBI) after lumpectomy for breast cancer
- minimum 18 years
- informed consent obtained, signed and dated before specific protocol procedures
Who cannot join
- mastectomy
- need for axillary irradiation
- bilateral breast irradiation
- previous irradiation at the same time
- mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
- patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial Comparing Prone and Supine Intensity-modulated Radiotherapy (IMRT) After Breast-conserving Surgery in Patients With Large Breast Volume at High Risk for Skin Toxicity and Fibrosis
84 patients with a cup size C or more will be randomized to receive intensity-modulated radiotherapy in supine or prone position.
- Conditions
- Breast Carcinoma
- Being tested
- radiation in prone position, radiation in supine position
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiation in prone positionBehavioural
radiation in prone position
radiation in supine positionBehavioural
radiation in supine position
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | prone intensity-modulated radiotherapy Receives: Behavioral: radiation in prone position |
| 2 | Active comparator | supine intensity-modulated radiotherapy Receives: Behavioral: radiation in supine position |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute moist desquamation
Measured: weekly during radiotherapy and 1 month after radiotherapy
Secondary outcomes (7)
Acute skin toxicity other than moist desquamation
Measured: weekly during radiotherapy and 1 month after radiotherapy
Late skin toxicity
Measured: at 6, 12, 18 and 24 months after radiotherapy
skin and lung fibrosis assessed with computed tomography
Measured: before radiotherapy and 1 month and 1 year after radiotherapy
Quality of life
Measured: at 1 year and 2 years after radiotherpay
dose-volume parameters
Measured: of planning
time of treatment delivery
Measured: daily during radiotherapy
single nucleotide polymorphisms associated with skin toxicity and breast fibrosis
Measured: 1 blood sample before radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2009 (estimated)
- Study startJul 2009
- Primary completionFeb 2021
- Study completion8 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Plan, France
- Responsible party
- Sponsor
- Investigators
- Wilfried De Neve, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00887523
- Sponsor's protocol ID
- 2009/184
- Status last verified
- Jun 2015
- First submitted
- 23 Apr 2009
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Vakaet V, Van Hulle H, Vergotte M, Schoepen M, Deseyne P, Van Greveling A, Post G, Speleers B, Paelinck L, Monten C, De Neve W, Veldeman L. 5-Year Outcomes of a Randomized Trial Comparing Prone and Supine Whole Breast Irradiation in Large-Breasted Women. Int J Radiat Oncol Biol Phys. 2021 Jul 1;110(3):766-771. doi: 10.1016/j.ijrobp.2021.01.026. Epub 2021 Jan 27.
PubMed 33508375
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Prone and Supine Intensity-modulated Radiotherapy (IMRT) After Breast-conserving Surgery in Patients With Large Breast Volume at High Risk for Skin Toxicity and Fibrosis
- ClinicalTrials.gov ID
- NCT00887523
- Acronym / sponsor ID
- 2009/184
- Conditions
- Breast Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- National Cancer Plan, France
- Study start
- Jul 2009 (actual)
- Primary completion
- Feb 2021 (actual)
- Study completion
- 8 Mar 2021 (actual)
- First posted
- 24 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
84 patients with a cup size C or more will be randomized to receive intensity-modulated radiotherapy in supine or prone position.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: radiation in prone positionprone intensity-modulated radiotherapy |
| 2 | Active comparator | Behavioral: radiation in supine positionsupine intensity-modulated radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- female patients
- multidisciplinary decision of adjuvant whole-breast irradiation (WBI) after lumpectomy for breast cancer
- minimum 18 years
- informed consent obtained, signed and dated before specific protocol procedures
Key exclusion criteria (6 listed)
- mastectomy
- need for axillary irradiation
- bilateral breast irradiation
- previous irradiation at the same time
- mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
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 |
|---|---|---|
| radiation in prone positionradiation in prone position | Behavioural | 1 |
| radiation in supine positionradiation in supine position | Behavioural | 2 |
Primary outcome
acute moist desquamation
Time frame: weekly during radiotherapy and 1 month after radiotherapy
7 secondary outcomes
Acute skin toxicity other than moist desquamation
Time frame: weekly during radiotherapy and 1 month after radiotherapy
Late skin toxicity
Time frame: at 6, 12, 18 and 24 months after radiotherapy
skin and lung fibrosis assessed with computed tomography
Time frame: before radiotherapy and 1 month and 1 year after radiotherapy
Quality of life
Time frame: at 1 year and 2 years after radiotherpay
dose-volume parameters
Time frame: of planning
time of treatment delivery
Time frame: daily during radiotherapy
single nucleotide polymorphisms associated with skin toxicity and breast fibrosis
Time frame: 1 blood sample before radiotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Derived from this study: PubMed 33508375Vakaet V, Van Hulle H, Vergotte M, Schoepen M, Deseyne P, Van Greveling A, Post G, Speleers B, Paelinck L, Monten C, De Neve W, Veldeman L. 5-Year Outcomes of a Randomized Trial Comparing Prone and Supine Whole Breast Irradiation in Large-Breasted Women. Int J Radiat Oncol Biol Phys. 2021 Jul 1;110(3):766-771. doi: 10.1016/j.ijrobp.2021.01.026. Epub 2021 Jan 27.
- website of the University Hospital GhentLink provided by the sponsor.
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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.
Wilfried De Neve, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiation in prone position and radiation in supine position in people with Breast Carcinoma, run by University Hospital, Ghent at 1 site in Belgium.
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 4 inclusion and 6 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 20 Dec 2022. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
acute moist desquamation (time frame: weekly during radiotherapy and 1 month after radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00887523, which also lists 1 linked publication.
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 20 Dec 2022.