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Completed

NCT Number: NCT01001728

SuPr Study (Supine Versus Prone Treatment Position in Breast Radiotherapy)

A randomised, two-arm, non-blinded crossover study investigating the impact of treatment position (prone versus supine) upon reproducibility of tumour bed position in patients undergoing breast radiotherapy following excision of early breast cancer.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

About this study

To establish whether or not the prone (face down) position reduces exposure of healthy tissue to radiation when compared to the supine position. To compare patient comfort and acceptability in each of the prone and supine positions. To perform a time and motion study for radiotherapy planned and delivered in each of the prone and supine positions.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Complete microscopic excision of early stage invasive ductal or lobular carcinoma (pT1-3b N0-1 M0) with breast preservation.
  • Paired titanium clips marking anterior, posterior, and radial walls of excision cavity
  • Breast cup size C or above
  • Recommendation for whole breast radiotherapy
  • No requirement for nodal irradiation
  • Ability to lie prone on breast board
  • For left-sided breast cancer patients, cardiac and LAD doses must be ≤10% greater than those predicted for the supine position.
  • For all patients, the following absolute dose constraints should be met: ≤5% of heart volume to receive 18Gy and ≤10% of ipsilateral lung volume to receive ≥20Gy
  • Age ≥18
  • PS ≤1
  • No previous radiotherapy to the affected breast
  • No concomitant herceptin
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
  • Written informed consent given according to ICH/GCP before registration/ randomisation.
  • Patients can only be randomised into this trial once.

Treatment and study plan

Imaging investigations (with radiation)

Radiation

Primary outcomes

  1. Interfraction reproducibility of tumour bed position (Reproducibility of tumour bed position in supine versus prone positions compared using the difference in mean daily displacement in tumour bed centre of gravity over a course of radiotherapy in 3D).

    Time frame: End of radiotherapy

Sponsors and collaborators

Lead sponsor

Royal Marsden NHS Foundation Trust

Other

Registry information

Official study title

A Randomised Trial Investigating the Prone Treatment Position as a Method of Sparing Healthy Tissues in Women Prescribed Breast Radiotherapy (SuPr Study)

Acronym: SuPr

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 27, 2009
Registry last updated
May 23, 2016

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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