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

NCT ID: NCT01001728

Last Updated: 2016-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2009-11-30

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prone Position

Patients will lie on their fronts on an in-house designed board comprising an arm positioning device registerable to the couch-top, together with a styrofoam/ memory foam mattress. The ipsilateral breast will drop through an aperture in the mattress. The distance from the nipple to the superior, inferior and lateral aspects of the aperture will be recorded along with the distance of the nipple from the couch-top. Arms will be extended as far as possible above the head and the position of the arm immobilisation handles recorded. The head will be turned to the contralateral side. The contralateral breast will be pulled laterally such that it is as flat as possible beneath the patient. Measurements will be taken in order to relate the position of the bi-lateral tattoos to the orthogonal lasers. A fourth tattoo will be marked on the patient's back in line with the A-P laser. The position will be reproduced at treatment using measurements from the tattoo to the laser.

Group Type: ACTIVE_COMPARATOR

Imaging investigations (with radiation)

Intervention Type: RADIATION

Supine position

For the supine position, patients will be positioned on a customized supine breast board co-registerable to the couch-top to CT and the treatment machines. Arms will be placed above the head in supports. Arm and head position will be recorded along with the angle of the board (which is adjusted such that the sternum is parallel to the couch-top). Tattoos will be marked bi-laterally and medially in a defined relationship to orthogonal lasers. The position will be reproduced at treatment using the above measurements, tattoos and lasers.

Group Type: ACTIVE_COMPARATOR

Imaging investigations (with radiation)

Intervention Type: RADIATION

Interventions

Imaging investigations (with radiation)

Intervention Type: RADIATION

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
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Professor John Yarnold

Role: PRINCIPAL_INVESTIGATOR

Royal Marsden NHS Foundation Trust

Locations

Royal Marsden NHS Foundation Trust

Sutton, Surrey, United Kingdom

Countries

United Kingdom

Other Identifiers

CCR3131

Identifier Type: -

Identifier Source: org_study_id