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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

Page last updated: August 23, 2015

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