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

Phase 3

Completed

• Conditions: Breast Cancer

• Registration Number: NCT01001728
• Lead Sponsor: Royal Marsden NHS Foundation Trust

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.

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-10-26
• Study First Submitted QC: 2009-10-26
• Study First Posted: 2009-10-27
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-20
• Last Update Posted: 2016-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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).	End of radiotherapy

Trial Locations

Locations (1)

Royal Marsden NHS Foundation Trust; 🇬🇧 Sutton, Surrey, United Kingdom