An interventional study of Prone Radiotherapy and Acceleration in Breast Neoplasms, Radiotherapy and Lymph Node Metastases, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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.
Device: Supine Radiotherapy · Radiation: Hypofractionation
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.
Device: Prone Radiotherapy · Radiation: Hypofractionation
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.
Radiation: Acceleration · Device: Supine Radiotherapy
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.
Device: Prone Radiotherapy · Radiation: Acceleration
Prone positioning for regional nodal irradiation using the crawl breast couch.
Also known as: Crawl position, Prone regional nodal irradiation
Accelerated irradiation in 5 fractions over 12 days with simultaneously integrated boost
Also known as: HAI-5, Hyper-accelerated irradiation, 5 fractions
Supine positioning for regional nodal irradiation using breastboard.
Also known as: Supine regional nodal irradiation
Moderate hypofractionation in 15 fractions over 3 weeks with simultaneously integrated boost
Also known as: Moderate hypofractionation
Breast retraction
Rate of breast retraction or volume loss after radiotherapy
Time frame: 2 years after radiotherapy
Acute toxicity - Dermatitis
Dermatitis measured by CTCAE v4.03
Time frame: Baseline and from radiation initiation until 8-16 days after radiation treatment
Acute toxicity - Desquamation
Desquamation measured by CTCAE v4.03
Time frame: Baseline and from radiation initiation until 8-16 days after radiation treatment
Acute toxicity - Breast oedema
Breast oedema measured by CTCAE v4.03
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: Baseline and from radiation initiation until 8-16 days after radiation treatment
Acute toxicity - Dysphagia
Dysphagia measured according to CTCAE v4.03
Time frame: Baseline and from radiation initiation until 8-16 days after radiation treatment
Acute toxicity - Dyspnea
Dyspnea measured according to CTCAE v4.03
Time frame: Baseline and from radiation initiation until 8-16 days after radiation treatment
Acute toxicity - Cough
Cough measured according to CTCAE v4.03
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Baseline, 1st visit after radiotherapy and at year 1, 2 and 5
Quality of life - General
EORTC questionnaire QLQ-C30
Time frame: 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
Time frame: At baseline and at 1, 2 and 5 years after radiotherapy
Locoregional and distant tumor control
Locoregional and distant tumor control
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 1st visit after radiotherapy and at year 1, 2 and 5
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Ghent