SuPr Study (Supine Versus Prone Treatment Position in Breast Radiotherapy)
Information source: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: Imaging investigations (with radiation) (Radiation)
Phase: Phase 3
Status: Recruiting
Sponsored by: Royal Marsden NHS Foundation Trust Official(s) and/or principal investigator(s): Professor John Yarnold, Principal Investigator, Affiliation: Royal Marsden NHS Foundation Trust
Overall contact: Professor John Yarnold, Phone: 02086613388, Email: john.yarnold@icr.ac.uk
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.
Clinical Details
Official title: A Randomised Trial Investigating the Prone Treatment Position as a Method of Sparing Healthy Tissues in Women Prescribed Breast Radiotherapy (SuPr Study)
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Primary outcome: 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).
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
- 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.
Locations and Contacts
Professor John Yarnold, Phone: 02086613388, Email: john.yarnold@icr.ac.uk
Royal Marsden NHS Foundation Trust, Sutton, Surrey SM2 5PT, United Kingdom; Recruiting
Additional Information
Starting date: November 2008
Last updated: October 26, 2009
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