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

Ghent University Hospital (UZ)

Status: Completed

Conditions: Lymph Node Metastases; Radiotherapy; Breast Neoplasms

Treatments: Radiation: Acceleration; Device: Supine Radiotherapy; Radiation: Hypofractionation; Device: Prone Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03280719

CIV-BE-17-06-020245 (Other Identifier)

EC/2017/0256

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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61 participants in 4 patient groups

Supine Hypofractionated Radiotherapy

Active Comparator group

Description:

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.

Treatment:

Radiation: Hypofractionation

Device: Supine Radiotherapy

Prone Hypofractionated Radiotherapy

Experimental group

Description:

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.

Treatment:

Device: Prone Radiotherapy

Radiation: Hypofractionation

Supine Accelerated Radiotherapy

Experimental group

Description:

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.

Treatment:

Device: Supine Radiotherapy

Radiation: Acceleration

Prone Accelerated Radiotherapy

Experimental group

Description:

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.

Treatment:

Device: Prone Radiotherapy

Radiation: Acceleration