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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Royal Marsden NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01001728
First received: October 26, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Radiation: Imaging investigations (with radiation)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Randomised Trial Investigating the Prone Treatment Position as a Method of Sparing Healthy Tissues in Women Prescribed Breast Radiotherapy (SuPr Study)

Resource links provided by NLM:


Further study details as provided by Royal Marsden NHS Foundation Trust:

Primary Outcome Measures:
  • 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). [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: November 2008
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Radiation: Imaging investigations (with radiation)
Active Comparator: 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.
Radiation: Imaging investigations (with radiation)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01001728

Contacts
Contact: Professor John Yarnold 02086613388 john.yarnold@icr.ac.uk

Locations
United Kingdom
Royal Marsden NHS Foundation Trust Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
Principal Investigator: Professor John Yarnold Royal Marsden NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Professor John R Yarnold, Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01001728     History of Changes
Other Study ID Numbers: CCR3131
Study First Received: October 26, 2009
Last Updated: October 26, 2009
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Royal Marsden NHS Foundation Trust:
Breast Cancer
Radiotherapy
Prone position

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 02, 2014