Trial Comparing Prone and Supine Intensity-modulated Radiotherapy (IMRT) After Breast-conserving Surgery in Patients With Large Breast Volume at High Risk for Skin Toxicity and Fibrosis

NCT00887523 | Completed

• 1 other identifier: 2009/184
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

84 patients with a cup size C or more will be randomized to receive intensity-modulated radiotherapy in supine or prone position.

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• acute moist desquamation

  weekly during radiotherapy and 1 month after radiotherapy

Secondary Outcomes (7)

• Acute skin toxicity other than moist desquamation

  weekly during radiotherapy and 1 month after radiotherapy

• Late skin toxicity

  at 6, 12, 18 and 24 months after radiotherapy

• skin and lung fibrosis assessed with computed tomography

  before radiotherapy and 1 month and 1 year after radiotherapy

• Quality of life

  at 1 year and 2 years after radiotherpay

• dose-volume parameters

  of planning

Study Arms (2)

1

EXPERIMENTAL

prone intensity-modulated radiotherapy

Behavioral: radiation in prone position

2

ACTIVE COMPARATOR

supine intensity-modulated radiotherapy

Behavioral: radiation in supine position

Interventions

radiation in prone position BEHAVIORAL

radiation in prone position

1

radiation in supine position BEHAVIORAL

radiation in supine position

2

Eligibility Criteria

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

You may qualify if:

• female patients
• multidisciplinary decision of adjuvant whole-breast irradiation (WBI) after lumpectomy for breast cancer
• minimum 18 years
• informed consent obtained, signed and dated before specific protocol procedures

You may not qualify if:

• mastectomy
• need for axillary irradiation
• bilateral breast irradiation
• previous irradiation at the same time
• mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
• patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.

Sponsors & Collaborators

• University Hospital, Ghent: lead
• National Cancer Plan, France: collaborator

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Publications (1)

• Vakaet V, Van Hulle H, Vergotte M, Schoepen M, Deseyne P, Van Greveling A, Post G, Speleers B, Paelinck L, Monten C, De Neve W, Veldeman L. 5-Year Outcomes of a Randomized Trial Comparing Prone and Supine Whole Breast Irradiation in Large-Breasted Women. Int J Radiat Oncol Biol Phys. 2021 Jul 1;110(3):766-771. doi: 10.1016/j.ijrobp.2021.01.026. Epub 2021 Jan 27.

  PMID: 33508375 DERIVED

Related Links

• website of the University Hospital Ghent

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiation; Prone Position; Supine Position

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena; Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Wilfried De Neve, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 23, 2009
• First Posted: April 24, 2009
• Study Start: July 1, 2009
• Primary Completion: February 1, 2021
• Study Completion: March 8, 2021
• Last Updated: December 20, 2022

Record last verified: 2015-06

Locations

BE (1)