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Completed

NCT Number: NCT03280719

Whole Breast + Lymph Node Irradiation: Prone Compared to Supine Position in 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.

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Key information

Conditions

Breast Neoplasms Behavior Breast Diseases Deception Lymph Node Metastases Lymphatic Metastasis Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Radiotherapy Skin Diseases Skin and Connective Tissue Diseases Social Behavior

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Radiotherapy department, UZ Ghent

Ghent, Oost-Vlaanderen, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prone Radiotherapy

Device

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

Other names: Crawl position, Prone regional nodal irradiation

Acceleration

Radiation

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

Other names: HAI-5, Hyper-accelerated irradiation, 5 fractions

Supine Radiotherapy

Device

Supine positioning for regional nodal irradiation using breastboard.

Other names: Supine regional nodal irradiation

hypofractionation

Radiation

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

Other names: Moderate hypofractionation

Primary outcomes

  1. Breast retraction

    Time frame: 2 years after radiotherapy

    Rate of breast retraction or volume loss after radiotherapy

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Acronym: PRO-SURF

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Sep 12, 2017
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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