Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Neoplasm Metastasis

Lymphatic Metastasis

Neoplastic Processes

Breast Diseases

Skin Diseases

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.

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.

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.

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.

Prone positioning for regional nodal irradiation using the crawl breast couch.

Prone Radiotherapy

Accelerated irradiation in 5 fractions over 12 days with simultaneously integrated boost

Acceleration

Supine positioning for regional nodal irradiation using breastboard.

Supine Radiotherapy

Moderate hypofractionation in 15 fractions over 3 weeks with simultaneously integrated boost

Hypofractionation

Katrien Vandecasteele, MD, PhD

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.

Whole Breast + Lymph Node Irradiation: Prone Compared to Supine Position in 15 or 5 Fractions

Whole Breast (WB) + Lymph Node Irradiation (LNI): Prone Compared to Supine Position in a Randomized Study With 15 or 5 Fractions

Rate of breast retraction or volume loss after radiotherapy

Shoulder range of motion measured by maximal excursion in abduction-adduction and anteversion-retroversion, in degrees from anatomical reference position

Arm circumference measured in cm 15 cm above and below medial epicondyle

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)

Sense of breast heaviness defined as present or absent.

Itching in the breast on a scale: 0 (no itching) - 1 (occasional itching) - 2 (regular itching)

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)

Sense of arm heaviness defined as present or absent.

Pain in the irradiated shoulder as defined on a scale: 0 (no pain) - 1 (occasional pain) - 2 (regular pain)

Impaired shoulder mobility on the irradiated side defined as present or absent

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.

Dysphagia measured according to CTCAE v4.03

Dyspnea measured according to CTCAE v4.03

Troponin T value at last treatment session ± 1 day compared with baseline measurement.

breast oedema, telangiectasia, color changes, fibrosis, shoulder symptoms, breast symptoms, arm symptoms, brachial plexopathy, heart toxicity, dyspnea, thyroid function, pain, fatigue.

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

Supplementing the general quality of life outcome (QLQ-C30) with breast specific questionnaire using the EORTC QLQ-BR23 tool

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.

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

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.

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.

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.

Cost-Utility Analysis (CUA) using the EuroQoL 5D tool.

University Ghent

Patients will lie on their fronts on an in-house designed board comprising an arm positioning device registerable to the couch-top, together with a styrofoam/ memory foam mattress. The ipsilateral breast will drop through an aperture in the mattress. The distance from the nipple to the superior, inferior and lateral aspects of the aperture will be recorded along with the distance of the nipple from the couch-top. Arms will be extended as far as possible above the head and the position of the arm immobilisation handles recorded. The head will be turned to the contralateral side. The contralateral breast will be pulled laterally such that it is as flat as possible beneath the patient. Measurements will be taken in order to relate the position of the bi-lateral tattoos to the orthogonal lasers. A fourth tattoo will be marked on the patient's back in line with the A-P laser. The position will be reproduced at treatment using measurements from the tattoo to the laser.

For the supine position, patients will be positioned on a customized supine breast board co-registerable to the couch-top to CT and the treatment machines. Arms will be placed above the head in supports. Arm and head position will be recorded along with the angle of the board (which is adjusted such that the sternum is parallel to the couch-top). Tattoos will be marked bi-laterally and medially in a defined relationship to orthogonal lasers. The position will be reproduced at treatment using the above measurements, tattoos and lasers.

Imaging investigations (with radiation)

Professor John Yarnold

A randomised, two-arm, non-blinded crossover study investigating the impact of treatment position (prone versus supine) upon reproducibility of tumour bed position in patients undergoing breast radiotherapy following excision of early breast cancer.

To establish whether or not the prone (face down) position reduces exposure of healthy tissue to radiation when compared to the supine position. To compare patient comfort and acceptability in each of the prone and supine positions. To perform a time and motion study for radiotherapy planned and delivered in each of the prone and supine positions.

SuPr Study (Supine Versus Prone Treatment Position in Breast Radiotherapy)

A Randomised Trial Investigating the Prone Treatment Position as a Method of Sparing Healthy Tissues in Women Prescribed Breast Radiotherapy (SuPr Study)

Royal Marsden NHS Foundation Trust

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma in Situ

Respiratory Aspiration

Breast Carcinoma In Situ

Carcinoma, Intraductal, Noninfiltrating

Carcinoma, Ductal, Breast

Respiration Disorders

Respiratory Tract Diseases

Patients attend a simulation visit and undergo two CT scans, one in the prone position and one in the supine position with DIBH. Within 1 week after the simulation visit, patients undergo radiation therapy either in the supine position with DIBH or in the prone position daily for 15-30 consecutive days as per physician's prescription.

Undergo RT either in the supine position with DIBH or in the prone position.

Radiation Therapy (RT)

Naamit Gerber, MD

This phase II trial studies how well deep inspiratory breath hold or prone breast radiation therapy works in reducing cardiac dose in patients with breast cancer or ductal carcinoma in situ. Deep inspiratory breath hold is a technique that involves a patient holding their breath during radiation to move the heart away from the breast to minimize radiation to the heart. Prone breast radiation therapy is a technique in which a patient receives treatment "face-down" to minimize the radiation to the rest of the body, including the heart and lungs. Comparing deep inspiratory breath hold to prone breast radiation therapy may help doctors improve radiation to the target while reducing radiation to healthy tissues surrounding the target.

Patients attend a simulation visit and undergo two CT scans, one in the prone position and one in the supine position with DIBH. Within 1 week after the simulation visit, patients undergo radiation therapy either in the supine position with DIBH or in the prone position daily for 15-30 consecutive days as per physician's prescription

A Prospective Trial to Compare Deep Inspiratory Breath Hold (DIBH) With Prone Breast Irradiation

Assess whether the mean cardiac dose in the supine DIBH plan differs from the mean cardiac dose in the prone plan within strata defined by total RT dose.

The volume of heart receiving \>20Gy in DIBH plan vs. prone plan

The mean LAD dose in DIBH plan vs. prone plan

The maximum LAD dose in DIBH plan vs. prone plan

The mean ipsilateral lung dose in DIBH plan vs. prone plan

The volume of ipsilateral lung receiving \>20Gy in DIBH plan vs. prone plan

The volume of the contralateral breast receiving \>5Gy in DIBH plan vs. prone plan

The maximum point dose to PTV breast in DIBH plan vs. prone plan

The maximum separation in DIBH plan vs. prone plan

Distance from the mid-sternum to the nipple when the patient is in the prone position

PTV breast volume as calculated on the prone scan

The change in distance between the chest wall and heart (at the most lateral portion of the chestwall-heart interface) between the free breathing scout films and the DIBH scout films

Will be described by proportions and frequency distributions. Logistic regression will be used to assess how each of the covariates (primary and secondary endpoints) affects the probability of being selected to undergo RT using the supine DIBH plan. ROC curves will be generated for various cut-points of the true proportion of patients requiring the supine DIBH plan.

NYU Langone Health

Musculoskeletal Diseases

Wounds and Injuries

Scoliosis

Fractures, Bone

Constriction, Pathologic

Spondylolisthesis

Spinal Stenosis

Spinal Fractures

Spinal Curvatures

Spinal Diseases

Bone Diseases

Spondylolysis

Spondylosis

Spinal Injuries

Back Injuries

Philips Intelivue MP70 monitor (Intellivue MP70, Philips medical Systems, Suresnes, France) -a radial arterial cannula is inserted and arterial pressure waveforms are monitored through Philips Intelivue MP70 monitor. In the monitor, PPVauto is displayed in real-time. It is based on automatic detection algorithms, kernel smoothing, and rank-order filters.

Philips Intelivue MP70 monitor

PVI is the measure of the dynamic changes in the Perfusion Index (PI) that occur during one or more complete respiratory cycles. A rainbow Pulse CO-Oximetry sensor is attached to the patient's finger and the PVI is displayed in real-time on the Root monitor.

Pleth Variability Index (PVI)

Appropriate fluid management is an important part of anesthesia in patients undergoing surgery, and several dynamic indices have been suggested to have high predictability for fluid responsiveness in patients receiving mechanical ventilation. Among various surgical positions, the prone position is known to cause unique physiologic and hemodynamic changes and affect the predictability and cut-off values of dynamic indices for fluid responsiveness. A previous study reported that pulse pressure variation (PPV) and corrected flow time were able to predict fluid responsiveness with relatively high accuracy in patients undergoing spine surgery in the prone position using a Wilson frame. However, the Jackson frame is known to have less effects on the cardiovascular system compared to the Wilson frame, and therefore may be physiologically more appropriate in patients undergoing surgery in the prone position. The pleth variability index (PVI) is a dynamic index that can be monitored non-invasively in patients under mechanical ventilation. The present study aims evaluate the validity of PPV and pleth variability index (PVI) as predictors of fluid responsiveness in the supine and prone positions in patients undergoing posterior lumbar spinal fusion using the Jackson table.

Assessing the Diagnostic Accuracy of Corrected Flow Time (FTc) and Pleth Variability Index (PVI) as Predictors of Fluid Responsiveness in Patients in the Prone Position Using the Jackson Table

Fluid responsiveness predictability of FTc and PVI in patients undergoing posterior lumbar fusion in the prone position by using the Jackson frame by calculating area under the curve of the ROC curve.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Whole Breast + Lymph Node Irradiation: Prone Compared to Supine Position in 15 or 5 Fractions	NCT03280719	Breast Neoplasm... Radiotherapy Lymph Node Meta...	Prone Radiother... Acceleration Supine Radiothe... Hypofractionati...	18 Years -	University Hospital, Ghent
SuPr Study (Supine Versus Prone Treatment Position in Breast Radiotherapy)	NCT01001728	Breast Cancer	Imaging investi...	18 Years -	Royal Marsden NHS Foundation Trust
A Prospective Trial to Compare Deep Inspiratory Breath Hold (DIBH) With Prone Breast Irradiation	NCT03437161	Breast Cancer	Radiation Thera...	18 Years -	NYU Langone Health
A Prospective Trial to Compare Deep Inspiratory Breath Hold (DIBH) With Prone Breast Irradiation	NCT03437161	Breast Cancer	Radiation Thera...	18 Years -	NYU Langone Health
Assessing the Diagnostic Accuracy of Corrected Flow Time (FTc) and Pleth Variability Index (PVI) as Predictors of Fluid Responsiveness in Patients in the Prone Position Using the Jackson Table	NCT02826889	Elective Poster... Spondylolisthes... Spinal Fracture... Scoliosis or Tu...	Philips Inteliv... Pleth Variabili...	19 Years - 75 Years	Yonsei University
SuPr Study (Supine Versus Prone Treatment Position in Breast Radiotherapy)	NCT01001728	Breast Cancer	Imaging investi...	18 Years -	Royal Marsden NHS Foundation Trust
Assessing the Diagnostic Accuracy of Corrected Flow Time (FTc) and Pleth Variability Index (PVI) as Predictors of Fluid Responsiveness in Patients in the Prone Position Using the Jackson Table	NCT02826889	Elective Poster... Spondylolisthes... Spinal Fracture... Scoliosis or Tu...	Philips Inteliv... Pleth Variabili...	19 Years - 75 Years	Yonsei University

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