Evaluation of tumour bed localisation and image-guided radiotherapy techniques for breast radiotherapy

Not Applicable

Completed

• Conditions: Breast cancer; Cancer; Malignant neoplasm of breast

• Registration Number: ISRCTN18654225
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust (UK)

Brief Summary

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/20605349

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2006-07-31
• Study Start: 2006-08-03
• Last Update Posted: 19 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

1. Histological confirmation of invasive carcinoma
2. Operable unilateral breast cancer requiring breast conservation surgery
3. Patient unlikely to require chemotherapy based on biopsy results
4. Patient characteristics e.g. grade 1-2, aged more than 50 years, oestrogen receptor positive, tumours less than 4 cm

Exclusion Criteria

1. Patients requiring mastectomy: there will be no tumour bed to localise
2. Patients likely to require chemotherapy prior to radiotherapy: we wish to complete the study within six months and chemotherapy patients require six months of treatment before radiotherapy is started. In addition, there is considerable shrinkage of the tumour bed after six months as a consequence of seroma re-absorption and tissue re-modelling, thus the tumour bed would be more difficult to identify in this group of patients

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean daily displacement in tumour bed centre of gravity expressed as three-dimensional co-ordinates.

Secondary Outcome Measures

Name	Time	Method
1. Mean total displacement in tumour bed centre of gravity during a course of radiotherapy<br>2. Mean change in tumour bed volume<br>3. Intra- and inter-observer variability in tumour bed localisation