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

NCT03280719 | Completed DMC

• 2 other identifiers: EC/2017/0256CIV-BE-17-06-020245
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms; Radiotherapy; Lymph Node Metastases

Keywords

Prone position; Supine position; Hypofractionation; Accelerated radiotherapy; Regional nodal irradiation

Outcome Measures

Primary Outcomes (1)

• Breast retraction

  Rate of breast retraction or volume loss after radiotherapy

  2 years after radiotherapy

Secondary Outcomes (28)

• Acute toxicity - Dermatitis

  Baseline and from radiation initiation until 8-16 days after radiation treatment

• Acute toxicity - Desquamation

  Baseline and from radiation initiation until 8-16 days after radiation treatment

• Acute toxicity - Breast oedema

  Baseline and from radiation initiation until 8-16 days after radiation treatment

• Acute toxicity - Shoulder range of motion

  Baseline and from radiation initiation until 8-16 days after radiation treatment

• Acute toxicity - Arm circumference

  Baseline and from radiation initiation until 8-16 days after radiation treatment

Study Arms (4)

Supine Hypofractionated Radiotherapy

ACTIVE COMPARATOR

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 Hypofractionated Radiotherapy

EXPERIMENTAL

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 Accelerated Radiotherapy

EXPERIMENTAL

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 Accelerated Radiotherapy

EXPERIMENTAL

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

Interventions

Prone Radiotherapy DEVICE

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

Also known as: Crawl position, Prone regional nodal irradiation

Prone Accelerated Radiotherapy; Prone Hypofractionated Radiotherapy

Acceleration RADIATION

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

Also known as: HAI-5, Hyper-accelerated irradiation, 5 fractions

Prone Accelerated Radiotherapy; Supine Accelerated Radiotherapy

Supine Radiotherapy DEVICE

Supine positioning for regional nodal irradiation using breastboard.

Also known as: Supine regional nodal irradiation

Supine Accelerated Radiotherapy; Supine Hypofractionated Radiotherapy

Hypofractionation RADIATION

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

Also known as: Moderate hypofractionation

Prone Hypofractionated Radiotherapy; Supine Hypofractionated Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Radiotherapy department, UZ Ghent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Related Publications (9)

• Early Breast Cancer Trialists' Collaborative Group (EBCTCG); Darby S, McGale P, Correa C, Taylor C, Arriagada R, Clarke M, Cutter D, Davies C, Ewertz M, Godwin J, Gray R, Pierce L, Whelan T, Wang Y, Peto R. Effect of radiotherapy after breast-conserving surgery on 10-year recurrence and 15-year breast cancer death: meta-analysis of individual patient data for 10,801 women in 17 randomised trials. Lancet. 2011 Nov 12;378(9804):1707-16. doi: 10.1016/S0140-6736(11)61629-2. Epub 2011 Oct 19.

  PMID: 22019144 BACKGROUND

• Clarke M, Collins R, Darby S, Davies C, Elphinstone P, Evans V, Godwin J, Gray R, Hicks C, James S, MacKinnon E, McGale P, McHugh T, Peto R, Taylor C, Wang Y; Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 Dec 17;366(9503):2087-106. doi: 10.1016/S0140-6736(05)67887-7.

  PMID: 16360786 BACKGROUND

• Mulliez T, Veldeman L, van Greveling A, Speleers B, Sadeghi S, Berwouts D, Decoster F, Vercauteren T, De Gersem W, Van den Broecke R, De Neve W. Hypofractionated whole breast irradiation for patients with large breasts: a randomized trial comparing prone and supine positions. Radiother Oncol. 2013 Aug;108(2):203-8. doi: 10.1016/j.radonc.2013.08.040. Epub 2013 Sep 14.

  PMID: 24044803 BACKGROUND

• Kirby AM, Evans PM, Donovan EM, Convery HM, Haviland JS, Yarnold JR. Prone versus supine positioning for whole and partial-breast radiotherapy: a comparison of non-target tissue dosimetry. Radiother Oncol. 2010 Aug;96(2):178-84. doi: 10.1016/j.radonc.2010.05.014. Epub 2010 Jun 17.

  PMID: 20561695 BACKGROUND

• Mulliez T, Van de Velde J, Veldeman L, De Gersem W, Vercauteren T, Speleers B, Degen H, Wouters J, Van Hoof T, van Greveling A, Monten C, Berwouts D, De Neve W. Deep inspiration breath hold in the prone position retracts the heart from the breast and internal mammary lymph node region. Radiother Oncol. 2015 Dec;117(3):473-6. doi: 10.1016/j.radonc.2015.09.030. Epub 2015 Oct 8.

  PMID: 26455452 BACKGROUND

• Mulliez T, Veldeman L, Speleers B, Mahjoubi K, Remouchamps V, Van Greveling A, Gilsoul M, Berwouts D, Lievens Y, Van den Broecke R, De Neve W. Heart dose reduction by prone deep inspiration breath hold in left-sided breast irradiation. Radiother Oncol. 2015 Jan;114(1):79-84. doi: 10.1016/j.radonc.2014.11.038. Epub 2014 Dec 9.

  PMID: 25497557 BACKGROUND

• Deseyne P, Speleers B, De Neve W, Boute B, Paelinck L, Van Hoof T, Van de Velde J, Van Greveling A, Monten C, Post G, Depypere H, Veldeman L. Whole breast and regional nodal irradiation in prone versus supine position in left sided breast cancer. Radiat Oncol. 2017 May 26;12(1):89. doi: 10.1186/s13014-017-0828-6.

  PMID: 28549483 BACKGROUND

• FAST Trialists group; Agrawal RK, Alhasso A, Barrett-Lee PJ, Bliss JM, Bliss P, Bloomfield D, Bowen J, Brunt AM, Donovan E, Emson M, Goodman A, Harnett A, Haviland JS, Kaggwa R, Morden JP, Robinson A, Simmons S, Stewart A, Sydenham MA, Syndikus I, Tremlett J, Tsang Y, Wheatley D, Venables K, Yarnold JR. First results of the randomised UK FAST Trial of radiotherapy hypofractionation for treatment of early breast cancer (CRUKE/04/015). Radiother Oncol. 2011 Jul;100(1):93-100. doi: 10.1016/j.radonc.2011.06.026.

  PMID: 21752481 BACKGROUND

• Monten C, Lievens Y, Olteanu LAM, Paelinck L, Speleers B, Deseyne P, Van Den Broecke R, De Neve W, Veldeman L. Highly Accelerated Irradiation in 5 Fractions (HAI-5): Feasibility in Elderly Women With Early or Locally Advanced Breast Cancer. Int J Radiat Oncol Biol Phys. 2017 Jul 15;98(4):922-930. doi: 10.1016/j.ijrobp.2017.01.229. Epub 2017 Feb 1.

  PMID: 28366576 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Lymphatic Metastasis; Deception

Interventions

Acceleration; Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Motion; Physical Phenomena; Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Study Officials

• Katrien Vandecasteele, MD, PhD

  UZ Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: September 12, 2017
• Study Start: September 15, 2017
• Primary Completion: July 7, 2020
• Study Completion: June 9, 2021
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

BE (1)