Breast NeoplasmsPRO-SURFNCT03280719
Whole Breast + Lymph Node Irradiation: Prone Compared to Supine Position in 15 or 5 Fractions
A study testing Prone Radiotherapy, Acceleration and Supine Radiotherapy in people with Breast Neoplasms and Radiotherapy, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
The goal of this trial is to evaluate the effect of the prone crawl treatment position and/or accelerated schedule on acute and late toxicities, as well as quality of life and time management for breast cancer patients receiving whole breast and regional nodal irradiation after breast conserving surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Radiotherapy, Lymph Node Metastases
- What is being tested?
- Prone Radiotherapy, Acceleration and Supine Radiotherapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Sep 2017to 9 Jun 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
- Breast conserving surgery
- AND Multidisciplinary decision of adjuvant whole breast + regional nodal irradiation
- AND Informed consent obtained, signed and dated before specific protocol procedures
Who cannot join
- Mastectomy
- OR Bilateral breast irradiation
- OR Distant metastasis/metastases
- OR previous irradiation to the thoracic, cervical or axillary region and overlap of fields with current treatment
- OR life expectancy of less than 2 years
- OR pre-existing conditions or comorbidities making toxicity evaluation difficult, e.g. skin disorders
Show all 9Show fewer
- OR pregnant or breast feeding
- OR mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
- OR patient unlikely to complete the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Whole Breast (WB) + Lymph Node Irradiation (LNI): Prone Compared to Supine Position in a Randomized Study with 15 or 5 Fractions
The goal of this trial is to evaluate the effect of the prone crawl treatment position and/or accelerated schedule on acute and late toxicities, as well as quality of life and time management for breast cancer patients receiving whole breast and regional nodal irradiation after breast conserving surgery.
Read the detailed description
Locoregional radiotherapy after lumpectomy and axillary node dissection diminishes the locoregional recurrence risk at 10 years by 21,2 % in women with pathologically confirmed lymph node involvement.
Excess dose to organs at risk can lead to acute and late side effects, such as tissue damage, organ malfunction and secondary cancers. Radiotherapy in prone position has helped reduce these risks for whole breast radiotherapy only, but has not yet been adequately investigated for patients also requiring regional nodal irradiation. One of the reasons is that there is no optimal patient support device available to allow regional nodal irradiation in prone position. To this end, a novel positioning device was developed at our center, allowing regional nodal irradiation in prone position. It was called the crawl breast couch because the patient position resembles a phase from the crawl swimming technique. A previous planning study by Deseyne et al. using this device shows a benefit (i.e. reduced dose) for the ipsilateral lung, the thyroid, as well as a minor benefit for the right lung, and contralateral breast (which already receive very low relative doses) while maintaining similar target coverage when compared to supine positioning.
Apart from the paradigm shift from supine to prone radiotherapy, in recent years, it has become clear that breast cancer cells are more sensitive to fraction dose than originally presumed. Large randomized trials confirm this hypothesis: moderate hypofractionation schemes in 15 or 16 fractions are at least equivalent in tumor control and toxicity although the total dose is lower than the traditional 50 Gy in 25 fractions. Further acceleration to 5 fractions is expected to have an even larger radiobiological advantage regarding tumor control. Additional advantages are patient comfort and a better use of radiotherapy resources.
This randomized trial with 2 x 2 factorial design tests 2 interventions for patients with breast cancer requiring whole-breast and regional nodal irradiation: radiotherapy in prone position with a specifically designed patient support device called the crawl breast couch, and accelerated radiotherapy in 5 fractions. The standard arm in this trial is supine hypofractionated radiotherapy.
The goal of this trial is to evaluate the effect of the prone crawl treatment position and/or accelerated schedule on acute and late toxicities, as well as quality of life and time management for breast cancer patients receiving whole breast and regional nodal irradiation after breast conserving surgery.
- Conditions
- Breast Neoplasms, Radiotherapy, Lymph Node Metastases
- Being tested
- Prone Radiotherapy, Acceleration, Supine Radiotherapy, Hypofractionation
- Keywords
- Prone position, Supine position, Hypofractionation, Accelerated radiotherapy, Regional nodal irradiation
- Medical subject headings
- Breast Neoplasms, Lymphatic Metastasis, Deception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone RadiotherapyDevice
Also called Crawl position, Prone regional nodal irradiation
Prone positioning for regional nodal irradiation using the crawl breast couch.
AccelerationRadiation
Also called HAI-5, Hyper-accelerated irradiation, 5 fractions
Accelerated irradiation in 5 fractions over 12 days with simultaneously integrated boost
Supine RadiotherapyDevice
Also called Supine regional nodal irradiation
Supine positioning for regional nodal irradiation using breastboard.
HypofractionationRadiation
Also called Moderate hypofractionation
Moderate hypofractionation in 15 fractions over 3 weeks with simultaneously integrated boost
| Study group | Role | What they receive |
|---|---|---|
| Supine Hypofractionated Radiotherapy | Active comparator | Supine Radiotherapy and Hypofractionation:
Whole breast + regional nodal irradiation in supine position with a median dose of 15 x 2.67 Gy prescribed to the whole breast and nodal regions. Median dose of the simultaneously integrated boost is 3.12 Gy per fraction. Receives: Device: Supine Radiotherapy; Radiation: Hypofractionation |
| Prone Hypofractionated Radiotherapy | Experimental | Prone Radiotherapy and Hypofractionation:
Whole breast + regional nodal irradiation in prone position with a 15 x 2.67 Gy dose prescription to the whole breast and nodal regions. Median dose of the simultaneously integrated boost is 3.12 Gy per fraction. Receives: Device: Prone Radiotherapy; Radiation: Hypofractionation |
| Supine Accelerated Radiotherapy | Experimental | Supine Radiotherapy and Acceleration:
Whole breast + regional nodal irradiation in supine position with a median dose of 5 x 5.7 Gy to the whole breast. Lymph node regions receive a median dose of 5 x 5.4 Gy. Median dose of the simultaneously integrated boost is 6.2 Gy per fraction. Receives: Radiation: Acceleration; Device: Supine Radiotherapy |
| Prone Accelerated Radiotherapy | Experimental | Prone Radiotherapy and Acceleration:
Whole breast + regional nodal irradiation in prone position with a median dose of 5 x 5.7 Gy to the whole breast. Lymph node regions receive a median dose of 5 x 5.4 Gy. Median dose of the simultaneously integrated boost is 6.2 Gy per fraction. Receives: Device: Prone Radiotherapy; Radiation: Acceleration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast retraction
Rate of breast retraction or volume loss after radiotherapy
Measured: 2 years after radiotherapy
Secondary outcomes (28)
Acute toxicity - Dermatitis
Dermatitis measured by CTCAE v4.03
Measured: Baseline and from radiation initiation until 8-16 days after radiation treatment
Acute toxicity - Desquamation
Desquamation measured by CTCAE v4.03
Measured: Baseline and from radiation initiation until 8-16 days after radiation treatment
Acute toxicity - Breast oedema
Breast oedema measured by CTCAE v4.03
Measured: Baseline and from radiation initiation until 8-16 days after radiation treatment
Acute toxicity - Shoulder range of motion
Shoulder range of motion measured by maximal excursion in abduction-adduction and anteversion-retroversion, in degrees from anatomical reference position
Measured: Baseline and from radiation initiation until 8-16 days after radiation treatment
Acute toxicity - Arm circumference
Arm circumference measured in cm 15 cm above and below medial epicondyle
Measured: Baseline and from radiation initiation until 8-16 days after radiation treatment
Acute toxicity - Breast symptoms - pain
Breast pain measured on a scale: 0 (no pain) - 1 (pain on contact) - 2 (pain on contact and also occasionally spontaneous) - 3 (pain on contact and regularly spontaneous) - 4 (pain medication needed and specify which)
Measured: Baseline and from radiation initiation until 8-16 days after radiation treatment
Acute toxicity - Breast symptoms - sense of heaviness
Sense of breast heaviness defined as present or absent.
Measured: Baseline and from radiation initiation until 8-16 days after radiation treatment
Acute toxicity - Breast symptoms - itching
Itching in the breast on a scale: 0 (no itching) - 1 (occasional itching) - 2 (regular itching)
Measured: Baseline and from radiation initiation until 8-16 days after radiation treatment
Acute toxicity - Arm Symptoms - Pain
Arm pain measured on a scale: 0 (no pain) - 1 (pain on contact) - 2 (pain on contact and also occasionally spontaneous) - 3 (pain on contact and regularly spontaneous) - 4 (pain medication needed and specify which)
Measured: Baseline and from radiation initiation until 8-16 days after radiation treatment
Acute toxicity - Arm Symptoms - Sense of heaviness
Sense of arm heaviness defined as present or absent.
Measured: Baseline and from radiation initiation until 8-16 days after radiation treatment
Acute toxicity - Shoulder symptoms - Pain
Pain in the irradiated shoulder as defined on a scale: 0 (no pain) - 1 (occasional pain) - 2 (regular pain)
Measured: Baseline and from radiation initiation until 8-16 days after radiation treatment
Acute toxicity - Shoulder symptoms - Impaired shoulder mobility
Impaired shoulder mobility on the irradiated side defined as present or absent
Measured: Baseline and from radiation initiation until 8-16 days after radiation treatment
Acute toxicity - Pain not in arm/shoulder/breast
Pain present in any other region than arm, shoulder or breast, defined on a scale: 0 (no pain) - 1 (occasional pain) - 2 (regular pain). Painful locations are indicated on a figure.
Measured: Baseline and from radiation initiation until 8-16 days after radiation treatment
Acute toxicity - Dysphagia
Dysphagia measured according to CTCAE v4.03
Measured: Baseline and from radiation initiation until 8-16 days after radiation treatment
Acute toxicity - Dyspnea
Dyspnea measured according to CTCAE v4.03
Measured: Baseline and from radiation initiation until 8-16 days after radiation treatment
Acute toxicity - Cough
Cough measured according to CTCAE v4.03
Measured: Baseline and from radiation initiation until 8-16 days after radiation treatment
Acute toxicity - Cardiac toxicity
Troponin T value at last treatment session ± 1 day compared with baseline measurement.
Measured: Baseline and from radiation initiation until 8-16 days after radiation treatment
Non-breast retraction late treatment related toxicity
breast oedema, telangiectasia, color changes, fibrosis, shoulder symptoms, breast symptoms, arm symptoms, brachial plexopathy, heart toxicity, dyspnea, thyroid function, pain, fatigue.
Measured: Baseline and from 6 months post radiotherapy until 5 years after radiotherapy
Cosmesis
Photographic image analysis using BCCT.core using frontal images with different arm positions. Reported cosmetic outcome is evaluated with radiotherapy specific items of the Breast Q questionnaire
Measured: Baseline, 1st visit after radiotherapy and at year 1, 2 and 5
Quality of life - General
EORTC questionnaire QLQ-C30
Measured: At baseline and at 1, 2 and 5 years after radiotherapy
Quality of life - Breast specific questionnaire
Supplementing the general quality of life outcome (QLQ-C30) with breast specific questionnaire using the EORTC QLQ-BR23 tool
Measured: At baseline and at 1, 2 and 5 years after radiotherapy
Locoregional and distant tumor control
Locoregional and distant tumor control
Measured: At 1, 2 and 5 years after radiotherapy
Treatment duration
Time registration from the moment the patient climbs the treatment couch until end of radiation. The first fraction is not measured as unforeseen problems in the workflow, questions or difficulties might delay treatment and falsify the results. The moment the patient mounts the treatment couch as well as the moment she climbs down, will be registered using a remote sensor. The beam on time is automatically registered by the treatment software.
Measured: At 3 weeks
Dose parameters of target tissues/organs at risk
Data extracted from dose-volume histograms (DVHs) and associated DVH planning files. the data are extracted from the developped treatment plan before treatment is initiated. Discrete values will be evaluated for all patients, more precisely the following:
D02 as a surrogate for Dmax, D05, D50, D95, D100, mean dose. All these values are reported in Gray (Gy)
Parameters evaluated for OARs:
- Mean dose, D02, D05, all in Gray
Measured: After treatment planning (Week 1-2 after inclusion)
Volume parameters of targets/organs at risk/hot spots - volume of the structures
Data extracted from dose-volume histograms (DVHs) and associated DVH planning files. the data are extracted from the developped treatment plan before treatment is initiated.
Volume of the targets and organs at risk is measured in cubic centimeters (cm³). Hot spots are defined as regions receiving either 105 or 107 % of the prescribed dose or more.
Measured: After treatment planning (Week 1-2 after inclusion)
Volume parameters of targets/organs at risk - relative volume receiving a certain dose
Data extracted from dose-volume histograms (DVHs) and associated DVH planning files. the data are extracted from the developped treatment plan before treatment is initiated.
For Organs at risk, a V5, V10, V20, V30 will be calculated. This is the relative volume of a the structure receiving a dose of 5, 10, 20 or 30 Gy. The value is measured as a percentage (%) of the total structure volume.
Measured: After treatment planning (Week 1-2 after inclusion)
Setup accuracy
Cone beam computed tomography verification directly prior to each scheduled radiation treatment session to determine shift between planned positioning and actual positioning. Shifts are performed and registered in laterolateral, craniocaudal and anteroposterior directions. No rotations are performed.
Measured: Before each scheduled radiation treatment session (every treatment day starting from radiotherapy start until ± 3 weeks later)
Treatment cost
Cost-Utility Analysis (CUA) using the EuroQoL 5D tool.
Measured: Baseline, 1st visit after radiotherapy and at year 1, 2 and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start15 Sep 2017
- Primary completion7 Jul 2020
- Study completion9 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies 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
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katrien Vandecasteele, MD, PhD, Principal investigator, UZ Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280719
- Sponsor's protocol ID
- EC/2017/0256
- Other IDs
- CIV-BE-17-06-020245
- Acronym
- PRO-SURF
- Status last verified
- Sep 2024
- First submitted
- 2 Aug 2017
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Early Breast Cancer Trialists' Collaborative Group (EBCTCG); Darby S, McGale P, Correa C, Taylor C, Arriagada R, Clarke M, Cutter D, Davies C, Ewertz M, Godwin J, Gray R, Pierce L, Whelan T, Wang Y, Peto R. Effect of radiotherapy after breast-conserving surgery on 10-year recurrence and 15-year breast cancer death: meta-analysis of individual patient data for 10,801 women in 17 randomised trials. Lancet. 2011 Nov 12;378(9804):1707-16. doi: 10.1016/S0140-6736(11)61629-2. Epub 2011 Oct 19.
PubMed 22019144Clarke M, Collins R, Darby S, Davies C, Elphinstone P, Evans V, Godwin J, Gray R, Hicks C, James S, MacKinnon E, McGale P, McHugh T, Peto R, Taylor C, Wang Y; Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 Dec 17;366(9503):2087-106. doi: 10.1016/S0140-6736(05)67887-7.
PubMed 16360786Mulliez T, Veldeman L, van Greveling A, Speleers B, Sadeghi S, Berwouts D, Decoster F, Vercauteren T, De Gersem W, Van den Broecke R, De Neve W. Hypofractionated whole breast irradiation for patients with large breasts: a randomized trial comparing prone and supine positions. Radiother Oncol. 2013 Aug;108(2):203-8. doi: 10.1016/j.radonc.2013.08.040. Epub 2013 Sep 14.
PubMed 24044803Kirby AM, Evans PM, Donovan EM, Convery HM, Haviland JS, Yarnold JR. Prone versus supine positioning for whole and partial-breast radiotherapy: a comparison of non-target tissue dosimetry. Radiother Oncol. 2010 Aug;96(2):178-84. doi: 10.1016/j.radonc.2010.05.014. Epub 2010 Jun 17.
PubMed 20561695Mulliez T, Van de Velde J, Veldeman L, De Gersem W, Vercauteren T, Speleers B, Degen H, Wouters J, Van Hoof T, van Greveling A, Monten C, Berwouts D, De Neve W. Deep inspiration breath hold in the prone position retracts the heart from the breast and internal mammary lymph node region. Radiother Oncol. 2015 Dec;117(3):473-6. doi: 10.1016/j.radonc.2015.09.030. Epub 2015 Oct 8.
PubMed 26455452Mulliez T, Veldeman L, Speleers B, Mahjoubi K, Remouchamps V, Van Greveling A, Gilsoul M, Berwouts D, Lievens Y, Van den Broecke R, De Neve W. Heart dose reduction by prone deep inspiration breath hold in left-sided breast irradiation. Radiother Oncol. 2015 Jan;114(1):79-84. doi: 10.1016/j.radonc.2014.11.038. Epub 2014 Dec 9.
PubMed 25497557Deseyne P, Speleers B, De Neve W, Boute B, Paelinck L, Van Hoof T, Van de Velde J, Van Greveling A, Monten C, Post G, Depypere H, Veldeman L. Whole breast and regional nodal irradiation in prone versus supine position in left sided breast cancer. Radiat Oncol. 2017 May 26;12(1):89. doi: 10.1186/s13014-017-0828-6.
PubMed 28549483FAST Trialists group; Agrawal RK, Alhasso A, Barrett-Lee PJ, Bliss JM, Bliss P, Bloomfield D, Bowen J, Brunt AM, Donovan E, Emson M, Goodman A, Harnett A, Haviland JS, Kaggwa R, Morden JP, Robinson A, Simmons S, Stewart A, Sydenham MA, Syndikus I, Tremlett J, Tsang Y, Wheatley D, Venables K, Yarnold JR. First results of the randomised UK FAST Trial of radiotherapy hypofractionation for treatment of early breast cancer (CRUKE/04/015). Radiother Oncol. 2011 Jul;100(1):93-100. doi: 10.1016/j.radonc.2011.06.026.
PubMed 21752481Monten C, Lievens Y, Olteanu LAM, Paelinck L, Speleers B, Deseyne P, Van Den Broecke R, De Neve W, Veldeman L. Highly Accelerated Irradiation in 5 Fractions (HAI-5): Feasibility in Elderly Women With Early or Locally Advanced Breast Cancer. Int J Radiat Oncol Biol Phys. 2017 Jul 15;98(4):922-930. doi: 10.1016/j.ijrobp.2017.01.229. Epub 2017 Feb 1.
PubMed 28366576
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Breast (WB) + Lymph Node Irradiation (LNI): Prone Compared to Supine Position in a Randomized Study with 15 or 5 Fractions
- ClinicalTrials.gov ID
- NCT03280719
- Acronym / sponsor ID
- PRO-SURF / EC/2017/0256
- Conditions
- Breast Neoplasms, Radiotherapy, Lymph Node Metastases
- Keywords
- Prone position, Supine position, Hypofractionation, Accelerated radiotherapy, Regional nodal irradiation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 7 Jul 2020 (actual)
- Study completion
- 9 Jun 2021 (actual)
- First posted
- 12 Sep 2017 (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 goal of this trial is to evaluate the effect of the prone crawl treatment position and/or accelerated schedule on acute and late toxicities, as well as quality of life and time management for breast cancer patients receiving whole breast and regional nodal irradiation after breast conserving surgery.
Detailed description
Locoregional radiotherapy after lumpectomy and axillary node dissection diminishes the locoregional recurrence risk at 10 years by 21,2 % in women with pathologically confirmed lymph node involvement.
Excess dose to organs at risk can lead to acute and late side effects, such as tissue damage, organ malfunction and secondary cancers. Radiotherapy in prone position has helped reduce these risks for whole breast radiotherapy only, but has not yet been adequately investigated for patients also requiring regional nodal irradiation. One of the reasons is that there is no optimal patient support device available to allow regional nodal irradiation in prone position. To this end, a novel positioning device was developed at our center, allowing regional nodal irradiation in prone position. It was called the crawl breast couch because the patient position resembles a phase from the crawl swimming technique. A previous planning study by Deseyne et al. using this device shows a benefit (i.e. reduced dose) for the ipsilateral lung, the thyroid, as well as a minor benefit for the right lung, and contralateral breast (which already receive very low relative doses) while maintaining similar target coverage when compared to supine positioning.
Apart from the paradigm shift from supine to prone radiotherapy, in recent years, it has become clear that breast cancer cells are more sensitive to fraction dose than originally presumed. Large randomized trials confirm this hypothesis: moderate hypofractionation schemes in 15 or 16 fractions are at least equivalent in tumor control and toxicity although the total dose is lower than the traditional 50 Gy in 25 fractions. Further acceleration to 5 fractions is expected to have an even larger radiobiological advantage regarding tumor control. Additional advantages are patient comfort and a better use of radiotherapy resources.
This randomized trial with 2 x 2 factorial design tests 2 interventions for patients with breast cancer requiring whole-breast and regional nodal irradiation: radiotherapy in prone position with a specifically designed patient support device called the crawl breast couch, and accelerated radiotherapy in 5 fractions. The standard arm in this trial is supine hypofractionated radiotherapy.
The goal of this trial is to evaluate the effect of the prone crawl treatment position and/or accelerated schedule on acute and late toxicities, as well as quality of life and time management for breast cancer patients receiving whole breast and regional nodal irradiation after breast conserving surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Supine Hypofractionated Radiotherapy | Active comparator | Device: Supine Radiotherapy, Radiation: HypofractionationSupine Radiotherapy and Hypofractionation: Whole breast + regional nodal irradiation in supine position with a median dose of 15 x 2.67 Gy prescribed to the whole breast and nodal regions. Median dose of the simultaneously integrated boost is 3.12 Gy per fraction. |
| Prone Hypofractionated Radiotherapy | Experimental | Device: Prone Radiotherapy, Radiation: HypofractionationProne Radiotherapy and Hypofractionation: Whole breast + regional nodal irradiation in prone position with a 15 x 2.67 Gy dose prescription to the whole breast and nodal regions. Median dose of the simultaneously integrated boost is 3.12 Gy per fraction. |
| Supine Accelerated Radiotherapy | Experimental | Radiation: Acceleration, Device: Supine RadiotherapySupine Radiotherapy and Acceleration: Whole breast + regional nodal irradiation in supine position with a median dose of 5 x 5.7 Gy to the whole breast. Lymph node regions receive a median dose of 5 x 5.4 Gy. Median dose of the simultaneously integrated boost is 6.2 Gy per fraction. |
| Prone Accelerated Radiotherapy | Experimental | Device: Prone Radiotherapy, Radiation: AccelerationProne Radiotherapy and Acceleration: Whole breast + regional nodal irradiation in prone position with a median dose of 5 x 5.7 Gy to the whole breast. Lymph node regions receive a median dose of 5 x 5.4 Gy. Median dose of the simultaneously integrated boost is 6.2 Gy per fraction. |
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)
- Breast conserving surgery
- AND Multidisciplinary decision of adjuvant whole breast + regional nodal irradiation
- AND Informed consent obtained, signed and dated before specific protocol procedures
Key exclusion criteria (9 listed)
- Mastectomy
- OR Bilateral breast irradiation
- OR Distant metastasis/metastases
- OR previous irradiation to the thoracic, cervical or axillary region and overlap of fields with current treatment
- OR life expectancy of less than 2 years
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 RadiotherapyAlso: Crawl position, Prone regional nodal irradiationProne positioning for regional nodal irradiation using the crawl breast couch. | Device | Prone Accelerated Radiotherapy, Prone Hypofractionated Radiotherapy |
| AccelerationAlso: HAI-5, Hyper-accelerated irradiation, 5 fractionsAccelerated irradiation in 5 fractions over 12 days with simultaneously integrated boost | Radiation | Prone Accelerated Radiotherapy, Supine Accelerated Radiotherapy |
| Supine RadiotherapyAlso: Supine regional nodal irradiationSupine positioning for regional nodal irradiation using breastboard. | Device | Supine Accelerated Radiotherapy, Supine Hypofractionated Radiotherapy |
| HypofractionationAlso: Moderate hypofractionationModerate hypofractionation in 15 fractions over 3 weeks with simultaneously integrated boost | Radiation | Prone Hypofractionated Radiotherapy, Supine Hypofractionated Radiotherapy |
Primary outcome
Breast retraction
Time frame: 2 years after radiotherapy
Rate of breast retraction or volume loss after radiotherapy
28 secondary outcomes
Acute toxicity - Dermatitis
Time frame: Baseline and from radiation initiation until 8-16 days after radiation treatment
Acute toxicity - Desquamation
Time frame: Baseline and from radiation initiation until 8-16 days after radiation treatment
Acute toxicity - Breast oedema
Time frame: Baseline and from radiation initiation until 8-16 days after radiation treatment
Acute toxicity - Shoulder range of motion
Time frame: Baseline and from radiation initiation until 8-16 days after radiation treatment
Acute toxicity - Arm circumference
Time frame: Baseline and from radiation initiation until 8-16 days after radiation treatment
Acute toxicity - Breast symptoms - pain
Time frame: Baseline and from radiation initiation until 8-16 days after radiation treatment
Acute toxicity - Breast symptoms - sense of heaviness
Time frame: Baseline and from radiation initiation until 8-16 days after radiation treatment
Acute toxicity - Breast symptoms - itching
Time frame: Baseline and from radiation initiation until 8-16 days after radiation treatment
Acute toxicity - Arm Symptoms - Pain
Time frame: Baseline and from radiation initiation until 8-16 days after radiation treatment
Acute toxicity - Arm Symptoms - Sense of heaviness
Time frame: Baseline and from radiation initiation until 8-16 days after radiation treatment
Acute toxicity - Shoulder symptoms - Pain
Time frame: Baseline and from radiation initiation until 8-16 days after radiation treatment
Acute toxicity - Shoulder symptoms - Impaired shoulder mobility
Time frame: Baseline and from radiation initiation until 8-16 days after radiation treatment
Acute toxicity - Pain not in arm/shoulder/breast
Time frame: Baseline and from radiation initiation until 8-16 days after radiation treatment
Acute toxicity - Dysphagia
Time frame: Baseline and from radiation initiation until 8-16 days after radiation treatment
Acute toxicity - Dyspnea
Time frame: Baseline and from radiation initiation until 8-16 days after radiation treatment
Acute toxicity - Cough
Time frame: Baseline and from radiation initiation until 8-16 days after radiation treatment
Acute toxicity - Cardiac toxicity
Time frame: Baseline and from radiation initiation until 8-16 days after radiation treatment
Non-breast retraction late treatment related toxicity
Time frame: Baseline and from 6 months post radiotherapy until 5 years after radiotherapy
Cosmesis
Time frame: Baseline, 1st visit after radiotherapy and at year 1, 2 and 5
Quality of life - General
Time frame: At baseline and at 1, 2 and 5 years after radiotherapy
Quality of life - Breast specific questionnaire
Time frame: At baseline and at 1, 2 and 5 years after radiotherapy
Locoregional and distant tumor control
Time frame: At 1, 2 and 5 years after radiotherapy
Treatment duration
Time frame: At 3 weeks
Dose parameters of target tissues/organs at risk
Time frame: After treatment planning (Week 1-2 after inclusion)
Volume parameters of targets/organs at risk/hot spots - volume of the structures
Time frame: After treatment planning (Week 1-2 after inclusion)
Volume parameters of targets/organs at risk - relative volume receiving a certain dose
Time frame: After treatment planning (Week 1-2 after inclusion)
Setup accuracy
Time frame: Before each scheduled radiation treatment session (every treatment day starting from radiotherapy start until ± 3 weeks later)
Treatment cost
Time frame: Baseline, 1st visit after radiotherapy and at year 1, 2 and 5
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 19 Sep 2024.
- Background: PubMed 22019144Early Breast Cancer Trialists' Collaborative Group (EBCTCG); Darby S, McGale P, Correa C, Taylor C, Arriagada R, Clarke M, Cutter D, Davies C, Ewertz M, Godwin J, Gray R, Pierce L, Whelan T, Wang Y, Peto R. Effect of radiotherapy after breast-conserving surgery on 10-year recurrence and 15-year breast cancer death: meta-analysis of individual patient data for 10,801 women in 17 randomised trials. Lancet. 2011 Nov 12;378(9804):1707-16. doi: 10.1016/S0140-6736(11)61629-2. Epub 2011 Oct 19.
- Background: PubMed 16360786Clarke M, Collins R, Darby S, Davies C, Elphinstone P, Evans V, Godwin J, Gray R, Hicks C, James S, MacKinnon E, McGale P, McHugh T, Peto R, Taylor C, Wang Y; Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 Dec 17;366(9503):2087-106. doi: 10.1016/S0140-6736(05)67887-7.
- Background: PubMed 24044803Mulliez T, Veldeman L, van Greveling A, Speleers B, Sadeghi S, Berwouts D, Decoster F, Vercauteren T, De Gersem W, Van den Broecke R, De Neve W. Hypofractionated whole breast irradiation for patients with large breasts: a randomized trial comparing prone and supine positions. Radiother Oncol. 2013 Aug;108(2):203-8. doi: 10.1016/j.radonc.2013.08.040. Epub 2013 Sep 14.
- Background: PubMed 20561695Kirby AM, Evans PM, Donovan EM, Convery HM, Haviland JS, Yarnold JR. Prone versus supine positioning for whole and partial-breast radiotherapy: a comparison of non-target tissue dosimetry. Radiother Oncol. 2010 Aug;96(2):178-84. doi: 10.1016/j.radonc.2010.05.014. Epub 2010 Jun 17.
- Background: PubMed 26455452Mulliez T, Van de Velde J, Veldeman L, De Gersem W, Vercauteren T, Speleers B, Degen H, Wouters J, Van Hoof T, van Greveling A, Monten C, Berwouts D, De Neve W. Deep inspiration breath hold in the prone position retracts the heart from the breast and internal mammary lymph node region. Radiother Oncol. 2015 Dec;117(3):473-6. doi: 10.1016/j.radonc.2015.09.030. Epub 2015 Oct 8.
- Background: PubMed 25497557Mulliez T, Veldeman L, Speleers B, Mahjoubi K, Remouchamps V, Van Greveling A, Gilsoul M, Berwouts D, Lievens Y, Van den Broecke R, De Neve W. Heart dose reduction by prone deep inspiration breath hold in left-sided breast irradiation. Radiother Oncol. 2015 Jan;114(1):79-84. doi: 10.1016/j.radonc.2014.11.038. Epub 2014 Dec 9.
- Background: PubMed 28549483Deseyne P, Speleers B, De Neve W, Boute B, Paelinck L, Van Hoof T, Van de Velde J, Van Greveling A, Monten C, Post G, Depypere H, Veldeman L. Whole breast and regional nodal irradiation in prone versus supine position in left sided breast cancer. Radiat Oncol. 2017 May 26;12(1):89. doi: 10.1186/s13014-017-0828-6.
- Background: PubMed 21752481FAST Trialists group; Agrawal RK, Alhasso A, Barrett-Lee PJ, Bliss JM, Bliss P, Bloomfield D, Bowen J, Brunt AM, Donovan E, Emson M, Goodman A, Harnett A, Haviland JS, Kaggwa R, Morden JP, Robinson A, Simmons S, Stewart A, Sydenham MA, Syndikus I, Tremlett J, Tsang Y, Wheatley D, Venables K, Yarnold JR. First results of the randomised UK FAST Trial of radiotherapy hypofractionation for treatment of early breast cancer (CRUKE/04/015). Radiother Oncol. 2011 Jul;100(1):93-100. doi: 10.1016/j.radonc.2011.06.026.
- Background: PubMed 28366576Monten C, Lievens Y, Olteanu LAM, Paelinck L, Speleers B, Deseyne P, Van Den Broecke R, De Neve W, Veldeman L. Highly Accelerated Irradiation in 5 Fractions (HAI-5): Feasibility in Elderly Women With Early or Locally Advanced Breast Cancer. Int J Radiat Oncol Biol Phys. 2017 Jul 15;98(4):922-930. doi: 10.1016/j.ijrobp.2017.01.229. Epub 2017 Feb 1.
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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.
Katrien Vandecasteele, MD, PhD principal investigator
UZ 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 Prone Radiotherapy, Acceleration and Supine Radiotherapy in people with Breast Neoplasms and Radiotherapy, 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 3 inclusion and 9 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 19 Sep 2024. 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?
Breast retraction (time frame: 2 years 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 NCT03280719, which also lists 9 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 19 Sep 2024.