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Whole Breast + Lymph Node Irradiation: Prone Compared to Supine Position in 15 or 5 Fractions (PRO-SURF)

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ClinicalTrials.gov Identifier: NCT03280719
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent ( University Ghent )

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Radiotherapy Lymph Node Metastases Device: Prone Radiotherapy Radiation: Acceleration Device: Supine Radiotherapy Radiation: Hypofractionation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 388 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Whole Breast (WB) + Lymph Node Irradiation (LNI): Prone Compared to Supine Position in a Randomized Study With 15 or 5 Fractions
Actual Study Start Date : September 15, 2017
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Supine Hypofractionated Radiotherapy

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
Supine positioning for regional nodal irradiation using breastboard.
Other Name: Supine regional nodal irradiation

Radiation: Hypofractionation
Moderate hypofractionation in 15 fractions over 3 weeks with simultaneously integrated boost
Other Name: Moderate hypofractionation

Experimental: Prone Hypofractionated Radiotherapy

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
Prone positioning for regional nodal irradiation using the crawl breast couch.
Other Names:
  • Crawl position
  • Prone regional nodal irradiation

Radiation: Hypofractionation
Moderate hypofractionation in 15 fractions over 3 weeks with simultaneously integrated boost
Other Name: Moderate hypofractionation

Experimental: Supine Accelerated Radiotherapy

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
Accelerated irradiation in 5 fractions over 12 days with simultaneously integrated boost
Other Names:
  • HAI-5
  • Hyper-accelerated irradiation
  • 5 fractions

Device: Supine Radiotherapy
Supine positioning for regional nodal irradiation using breastboard.
Other Name: Supine regional nodal irradiation

Experimental: Prone Accelerated 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
Prone positioning for regional nodal irradiation using the crawl breast couch.
Other Names:
  • Crawl position
  • Prone regional nodal irradiation

Radiation: Acceleration
Accelerated irradiation in 5 fractions over 12 days with simultaneously integrated boost
Other Names:
  • HAI-5
  • Hyper-accelerated irradiation
  • 5 fractions




Primary Outcome Measures :
  1. Breast retraction [ Time Frame: 2 years after radiotherapy ]
    Rate of breast retraction or volume loss after radiotherapy


Secondary Outcome Measures :
  1. Acute toxicity - Dermatitis [ Time Frame: Baseline and from radiation initiation until 8-16 days after radiation treatment ]
    Dermatitis measured by CTCAE v4.03

  2. Acute toxicity - Desquamation [ Time Frame: Baseline and from radiation initiation until 8-16 days after radiation treatment ]
    Desquamation measured by CTCAE v4.03

  3. Acute toxicity - Breast oedema [ Time Frame: Baseline and from radiation initiation until 8-16 days after radiation treatment ]
    Breast oedema measured by CTCAE v4.03

  4. Acute toxicity - Shoulder range of motion [ Time Frame: Baseline and from radiation initiation until 8-16 days after radiation treatment ]
    Shoulder range of motion measured by maximal excursion in abduction-adduction and anteversion-retroversion, in degrees from anatomical reference position

  5. Acute toxicity - Arm circumference [ Time Frame: Baseline and from radiation initiation until 8-16 days after radiation treatment ]
    Arm circumference measured in cm 15 cm above and below medial epicondyle

  6. Acute toxicity - Breast symptoms - pain [ Time Frame: Baseline and from radiation initiation until 8-16 days after radiation treatment ]
    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)

  7. Acute toxicity - Breast symptoms - sense of heaviness [ Time Frame: Baseline and from radiation initiation until 8-16 days after radiation treatment ]
    Sense of breast heaviness defined as present or absent.

  8. Acute toxicity - Breast symptoms - itching [ Time Frame: Baseline and from radiation initiation until 8-16 days after radiation treatment ]
    Itching in the breast on a scale: 0 (no itching) - 1 (occasional itching) - 2 (regular itching)

  9. Acute toxicity - Arm Symptoms - Pain [ Time Frame: Baseline and from radiation initiation until 8-16 days after radiation treatment ]
    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)

  10. Acute toxicity - Arm Symptoms - Sense of heaviness [ Time Frame: Baseline and from radiation initiation until 8-16 days after radiation treatment ]
    Sense of arm heaviness defined as present or absent.

  11. Acute toxicity - Shoulder symptoms - Pain [ Time Frame: Baseline and from radiation initiation until 8-16 days after radiation treatment ]
    Pain in the irradiated shoulder as defined on a scale: 0 (no pain) - 1 (occasional pain) - 2 (regular pain)

  12. Acute toxicity - Shoulder symptoms - Impaired shoulder mobility [ Time Frame: Baseline and from radiation initiation until 8-16 days after radiation treatment ]
    Impaired shoulder mobility on the irradiated side defined as present or absent

  13. Acute toxicity - Pain not in arm/shoulder/breast [ Time Frame: Baseline and from radiation initiation until 8-16 days after radiation treatment ]
    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.

  14. Acute toxicity - Dysphagia [ Time Frame: Baseline and from radiation initiation until 8-16 days after radiation treatment ]
    Dysphagia measured according to CTCAE v4.03

  15. Acute toxicity - Dyspnea [ Time Frame: Baseline and from radiation initiation until 8-16 days after radiation treatment ]
    Dyspnea measured according to CTCAE v4.03

  16. Acute toxicity - Cough [ Time Frame: Baseline and from radiation initiation until 8-16 days after radiation treatment ]
    Cough measured according to CTCAE v4.03

  17. Acute toxicity - Cardiac toxicity [ Time Frame: Baseline and from radiation initiation until 8-16 days after radiation treatment ]
    Troponin T value at last treatment session ± 1 day compared with baseline measurement.

  18. Non-breast retraction late treatment related toxicity [ Time Frame: Baseline and from 6 months post radiotherapy until 5 years after radiotherapy ]
    breast oedema, telangiectasia, color changes, fibrosis, shoulder symptoms, breast symptoms, arm symptoms, brachial plexopathy, heart toxicity, dyspnea, thyroid function, pain, fatigue.

  19. Cosmesis [ Time Frame: Baseline, 1st visit after radiotherapy and at year 1, 2 and 5 ]
    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

  20. Quality of life - General [ Time Frame: At baseline and at 1, 2 and 5 years after radiotherapy ]
    EORTC questionnaire QLQ-C30

  21. Quality of life - Breast specific questionnaire [ Time Frame: At baseline and at 1, 2 and 5 years after radiotherapy ]
    Supplementing the general quality of life outcome (QLQ-C30) with breast specific questionnaire using the EORTC QLQ-BR23 tool

  22. Locoregional and distant tumor control [ Time Frame: At 1, 2 and 5 years after radiotherapy ]
    Locoregional and distant tumor control

  23. Treatment duration [ Time Frame: At 3 weeks ]
    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.

  24. Dose parameters of target tissues/organs at risk [ Time Frame: After treatment planning (Week 1-2 after inclusion) ]

    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


  25. Volume parameters of targets/organs at risk/hot spots - volume of the structures [ Time Frame: After treatment planning (Week 1-2 after inclusion) ]

    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.


  26. Volume parameters of targets/organs at risk - relative volume receiving a certain dose [ Time Frame: After treatment planning (Week 1-2 after inclusion) ]

    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.


  27. Setup accuracy [ Time Frame: Before each scheduled radiation treatment session (every treatment day starting from radiotherapy start until ± 3 weeks later) ]
    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.

  28. Treatment cost [ Time Frame: Baseline, 1st visit after radiotherapy and at year 1, 2 and 5 ]
    Cost-Utility Analysis (CUA) using the EuroQoL 5D tool.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Breast conserving surgery
  • AND Multidisciplinary decision of adjuvant whole breast + regional nodal irradiation
  • AND Informed consent obtained, signed and dated before specific protocol procedures

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03280719


Contacts
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Contact: Wilfried De Neve, MD, PhD +3293323015 wilfried.deneve@uzgent.be
Contact: Liv Veldeman, MD, PhD +3293323015 liv.veldeman@uzgent.be

Locations
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Belgium
Radiotherapy department, UZ Ghent Recruiting
Ghent, Oost-Vlaanderen, Belgium, 9000
Contact: Wilfried De Neve, MD, PhD    +32 9 332 30 15    wilfried.deneve@uzgent.be   
Contact: Liv Veldeman, MD, PhD    +32 9 332 30 15    liv.veldeman@uzgent.be   
Principal Investigator: Katrien Vandecasteele, MD, PhD         
Sub-Investigator: Pieter Deseyne, MD         
Sub-Investigator: Chris Monten, MD         
Sponsors and Collaborators
University Ghent
Investigators
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Principal Investigator: Katrien Vandecasteele, MD, PhD UZ Ghent
Publications:

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Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT03280719    
Other Study ID Numbers: EC/2017/0256
CIV-BE-17-06-020245 ( Other Identifier: EUDAMED )
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Ghent ( University Ghent ):
Prone position
Supine position
Hypofractionation
Accelerated radiotherapy
Regional nodal irradiation
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases