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

Breast Cancer Clinical Trial

— SuPr  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01001728
• Other study ID #: CCR3131
• Status: Completed
• Phase: Phase 3
• First received: October 26, 2009
• Last updated: May 20, 2016
• Start date: November 2008
• Est. completion date: November 2009

Study information

• Verified date: May 2016
• Source: Royal Marsden NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Radiation:
• Imaging investigations (with radiation)

Locations

Country	Name	City	State
United Kingdom	Royal Marsden NHS Foundation Trust	Sutton	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No