Breast Cancer FemaleNCT05179161
Validation of Prone Crawl Radiotherapy for Whole-breast Irradiation After Breast Conserving Surgery
A study testing Prone crawl positioning in people with Breast Cancer Female, run by University Hospital, Ghent.
Trial summary
The aim of this study is to validate the obtained results of setup precision, comfort and setup time. The possibility of using breath hold for heart sparing in combination with prone crawl position will be tested. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Prone crawl positioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 31 May 2016to 29 Mar 2017
- 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
- Non-metastasized breast carcinoma
- Multidisciplinary decision of adjuvant radiotherapy after lumpectomy for breast cancer
- Prone WBI without LNI indicated according to the department's guidelines, treatment schedule of at least 15 fractions
- Age ≥ 18 years
- Informed consent obtained, signed and dated before specific protocol procedures
Who cannot join
- < 18 years old
- Mastectomy
- Need for LNI
- Bilateral breast irradiation
- Partial breast irradiation
- Unable to be treated in prone position
Show all 11Show fewer
- Less than 15 treatment fractions planned
- Situs inversus
- Pregnant or breastfeeding
- 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
About this study
The aim of this study is to validate the obtained results of setup precision, comfort and setup time. The possibility of using breath hold for heart sparing in combination with prone crawl position will be tested. Forty patients (20 with left-sided and 20 with right-sided breast carcinoma) presenting for WBI without LNI after breast-conserving surgery will be included after signing informed consent.
Read the detailed description
This is a phase II non-randomized trial, where 40 patients will be treated for breast cancer requiring whole breast irradiation as per standard of care. Patients will be simulated and treated using the novel prone crawl position to a total dose of 40.05 Gy in 15 fractions of 2.67 Gy.
The trial aims to evaluate setup precision, patient comfort and setup time in the prone crawl positioning. Feasibility of deep inspiration breathhold will be tested and dosimetric parameters evaluated.
This is done through registration of setup errors at the time of treatment, questionnaires for comfort/discomfort scoring, time registration, toxicity scoring, and dosimetric analysis in treatment planning systems.
- Conditions
- Breast Cancer Female
- Being tested
- Prone crawl positioning
- Keywords
- Prone positioning, Prone crawl position, Radiotherapy, Whole breast irradiation, Setup errors, Patient comfort, Setup time, Deep inspiration breathhold, Dosimetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone crawl positioningDevice
Breast cancer patients are placed in a prone position with the ipsilateral arm besides the body rather than extended besides the head on a dedicated couch that provides the required support for maintaining this position.
| Study group | Role | What they receive |
|---|---|---|
| Prone crawl position | Experimental | Patients are placed in the prone crawl position for whole breast irradiation and are treated with 15 x 2,67 Gy (± boost treatment if required as per international guidelines) Receives: Device: Prone crawl positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Setup error
Setup errors are analyzed using Van Herk parameters obtained by rigid coregistration of treatment imaging with simulation imaging
Measured: During the intervention
Secondary outcomes (5)
Patient comfort
Patient comfort as assessed by questionnaire
Measured: immediately after the intervention
Setup Time
Time taken for setting up the patient for each fraction
Measured: During the intervention
Reproducibility of DIBH
The reproducibility and stability of deep inspiration breathhold is investigated by performing multiple breathhold manoevres during CT imaging at baseline, and comparing the relative geometric position of organs between on the acquired images for each patient. This will be evaluated by calculating the overlap index and dice similarity coefficien between these images.
Measured: At baseline
Acute toxicity
Acute side effects due to radiotherapy using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 toxicity scoring system, scoring toxicities from grade 0 (no toxicity) to grade 5 (death)
Measured: 6 months after treatment end
Dose to target and dose to organs at risk
Analysis is dose using the Dose-volume histogram (DVH) of targets and organs at risk, as obtained on CT simulation images. These DVH's are used to assess amount of radiation received by each organ and treatment target and assess the risk of treatment failure or treatment harm.
Measured: Before treatment initiation after CT simulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start31 May 2016
- Primary completion29 Sep 2016
- Study completion29 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liv Veldeman, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179161
- Sponsor's protocol ID
- EC-UZ-2016/0351
- Other IDs
- B670201628048
- Status last verified
- Oct 2021
- First submitted
- 19 Oct 2021
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing patient data is not planned
Publications
Deseyne P, Speleers B, De Neve W, Boute B, Paelinck L, Vakaet V, Van Hulle H, Schoepen M, Stouthandel M, Van Greveling A, Post G, Detand J, Monten C, Depypere H, Veldeman L. Crawl positioning improves set-up precision and patient comfort in prone whole breast irradiation. Sci Rep. 2020 Oct 2;10(1):16376. doi: 10.1038/s41598-020-72702-3.
PubMed 33009448Deseyne P, Speleers B, Paelinck L, De Gersem W, De Neve W, Schoepen M, Van Greveling A, Van Hulle H, Vakaet V, Post G, Monten C, Depypere H, Veldeman L. Reproducibility of repeated breathhold and impact of breathhold failure in whole breast and regional nodal irradiation in prone crawl position. Sci Rep. 2022 Feb 3;12(1):1887. doi: 10.1038/s41598-022-05957-7.
PubMed 35115610
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Prone Crawl Radiotherapy for Whole-breast Irradiation After Breast Conserving Surgery
- ClinicalTrials.gov ID
- NCT05179161
- Acronym / sponsor ID
- EC-UZ-2016/0351
- Conditions
- Breast Cancer Female
- Keywords
- Prone positioning, Prone crawl position, Radiotherapy, Whole breast irradiation, Setup errors, Patient comfort, Setup time, Deep inspiration breathhold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 31 May 2016 (actual)
- Primary completion
- 29 Sep 2016 (actual)
- Study completion
- 29 Mar 2017 (actual)
- First posted
- 5 Jan 2022 (actual)
- 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.
The aim of this study is to validate the obtained results of setup precision, comfort and setup time. The possibility of using breath hold for heart sparing in combination with prone crawl position will be tested. Forty patients (20 with left-sided and 20 with right-sided breast carcinoma) presenting for WBI without LNI after breast-conserving surgery will be included after signing informed consent.
Detailed description
This is a phase II non-randomized trial, where 40 patients will be treated for breast cancer requiring whole breast irradiation as per standard of care. Patients will be simulated and treated using the novel prone crawl position to a total dose of 40.05 Gy in 15 fractions of 2.67 Gy.
The trial aims to evaluate setup precision, patient comfort and setup time in the prone crawl positioning. Feasibility of deep inspiration breathhold will be tested and dosimetric parameters evaluated.
This is done through registration of setup errors at the time of treatment, questionnaires for comfort/discomfort scoring, time registration, toxicity scoring, and dosimetric analysis in treatment planning systems.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prone crawl position | Experimental | Device: Prone crawl positioningPatients are placed in the prone crawl position for whole breast irradiation and are treated with 15 x 2,67 Gy (± boost treatment if required as per international guidelines) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female patients
- Non-metastasized breast carcinoma
- Multidisciplinary decision of adjuvant radiotherapy after lumpectomy for breast cancer
- Prone WBI without LNI indicated according to the department's guidelines, treatment schedule of at least 15 fractions
- Age ≥ 18 years
Key exclusion criteria (11 listed)
- < 18 years old
- Mastectomy
- Need for LNI
- Bilateral breast irradiation
- Partial breast irradiation
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 |
|---|---|---|
| Prone crawl positioningBreast cancer patients are placed in a prone position with the ipsilateral arm besides the body rather than extended besides the head on a dedicated couch that provides the required support for maintaining this position. | Device | Prone crawl position |
Primary outcome
Setup error
Time frame: During the intervention
Setup errors are analyzed using Van Herk parameters obtained by rigid coregistration of treatment imaging with simulation imaging
5 secondary outcomes
Patient comfort
Time frame: immediately after the intervention
Setup Time
Time frame: During the intervention
Reproducibility of DIBH
Time frame: At baseline
Acute toxicity
Time frame: 6 months after treatment end
Dose to target and dose to organs at risk
Time frame: Before treatment initiation after CT simulation
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 5 Jan 2022.
- Results publication: PubMed 33009448Deseyne P, Speleers B, De Neve W, Boute B, Paelinck L, Vakaet V, Van Hulle H, Schoepen M, Stouthandel M, Van Greveling A, Post G, Detand J, Monten C, Depypere H, Veldeman L. Crawl positioning improves set-up precision and patient comfort in prone whole breast irradiation. Sci Rep. 2020 Oct 2;10(1):16376. doi: 10.1038/s41598-020-72702-3.
- Derived from this study: PubMed 35115610Deseyne P, Speleers B, Paelinck L, De Gersem W, De Neve W, Schoepen M, Van Greveling A, Van Hulle H, Vakaet V, Post G, Monten C, Depypere H, Veldeman L. Reproducibility of repeated breathhold and impact of breathhold failure in whole breast and regional nodal irradiation in prone crawl position. Sci Rep. 2022 Feb 3;12(1):1887. doi: 10.1038/s41598-022-05957-7.
- Individual participant dataSharing planned: No. Sharing patient data is not planned
Related trials for Breast Cancer Female
Recruiting
Decision Support for Chemoprevention
Breast Cancer
Not yet recruiting
Geriatric Oncology Assessment and Coping Skills Training for Older Women on Aromatase Inhibitor Therapy
Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated Arthralgia
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 1
A Phase I Study of CG-7321 Monotherapy or Combination Therapy in Advanced Solid Tumors
Advanced Solid Tumors, Breast Cancer
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.
Liv Veldeman, MD, PhD principal investigator
University Hospital, Ghent
Questions about this trial
What is this clinical trial studying?
A study testing Prone crawl positioning in people with Breast Cancer Female, run by University Hospital, Ghent.
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 6 inclusion and 11 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 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Setup error (time frame: During the intervention). 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 NCT05179161, which also lists 2 linked publications.
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 5 Jan 2022.