A Randomised Trial Investigating the Prone Treatment Position as a Method of Sparing Healthy Tissues in Women Prescribed Breast Radiotherapy (SuPr Study)
18 Years
N/A
Female
Breast Cancer
Trial Information
A Randomised Trial Investigating the Prone Treatment Position as a Method of Sparing Healthy Tissues in Women Prescribed Breast Radiotherapy (SuPr 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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Outcome Measure:
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).
Safety Issue:
No
Principal Investigator
Professor John Yarnold
Investigator Role:
Principal Investigator
Investigator Affiliation:
Royal Marsden NHS Foundation Trust
Authority:
United Kingdom: Research Ethics Committee
Study ID:
CCR3131
NCT ID:
NCT01001728
Start Date:
November 2008
Completion Date:
November 2009
Related Keywords:
- Breast Cancer
- Breast Cancer
- Radiotherapy
- Prone position
- Breast Neoplasms
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