A Randomised Trial Investigating the Prone Treatment Position as a Method of Sparing Healthy Tissues in Women Prescribed Breast Radiotherapy (SuPr Study)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Royal Marsden NHS Foundation Trust
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- 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).
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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
- •No previous radiotherapy to the affected breast
- •No concomitant herceptin
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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