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Completed

NCT Number: NCT00887523

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

radiation in prone position

Behavioral

radiation in prone position

radiation in supine position

Behavioral

radiation in supine position

Primary outcomes

  1. acute moist desquamation

    Time frame: weekly during radiotherapy and 1 month after radiotherapy

Secondary outcomes

  1. Acute skin toxicity other than moist desquamation

    Time frame: weekly during radiotherapy and 1 month after radiotherapy

  2. Late skin toxicity

    Time frame: at 6, 12, 18 and 24 months after radiotherapy

  3. skin and lung fibrosis assessed with computed tomography

    Time frame: before radiotherapy and 1 month and 1 year after radiotherapy

  4. Quality of life

    Time frame: at 1 year and 2 years after radiotherpay

  5. dose-volume parameters

    Time frame: of planning

  6. time of treatment delivery

    Time frame: daily during radiotherapy

  7. single nucleotide polymorphisms associated with skin toxicity and breast fibrosis

    Time frame: 1 blood sample before radiotherapy

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • National Cancer Plan, France

Registry information

Official study title

Randomized Controlled 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

Important dates

Study start
2009
Primary completion
2021
Study completion
2021
First posted
Apr 24, 2009
Registry last updated
Dec 20, 2022

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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