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

ISRCTN	ISRCTN18654225
DOI	https://doi.org/10.1186/ISRCTN18654225
Protocol serial number	N/A
Sponsor	Cambridge University Hospitals NHS Foundation Trust (UK)
Funders	West Anglia Cancer Research Network (UK) (for payment of ISRCTN), No external funding has been sought, any small additional costs will be funded by participating centres

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Dr Charlotte Coles
Scientific

Oncology Centre
Box 193
Addenbrookes Hospital
Hills road
Cambridge
CB2 2QQ
United Kingdom

Phone	+44 (0)1223 596182
Email	charlotte.coles@addenbrookes.nhs.uk

Primary study design	Interventional
Study design	Interventional trial
Secondary study design	Other
Scientific title	Evaluation of tumour bed localisation and image-guided radiotherapy techniques for breast radiotherapy
Study acronym	Gold Seed Study
Study objectives	Develop an accurate and practical method of breast radiotherapy tumour bed localisation and tracking with Image-Guided Radiotherapy Techniques (IGRT), for implementation in oncology centres participating in the IMPORT HIGH Trial (ISRCTN47437448).
Ethics approval(s)	Northern and Yorkshire research ethics committee (ref: 05/MRE03/74).
Health condition(s) or problem(s) studied	Breast cancer
Intervention	1. Imaging investigations (with radiation) 2. Additional portal imaging field and Computed Tomography (CT) scan 3. Insertion of gold breast markers at surgery
Intervention type	Other
Primary outcome measure(s)	Mean daily displacement in tumour bed centre of gravity expressed as three-dimensional co-ordinates.
Key secondary outcome measure(s)	1. Mean total displacement in tumour bed centre of gravity during a course of radiotherapy 2. Mean change in tumour bed volume 3. Intra- and inter-observer variability in tumour bed localisation
Completion date	31/07/2006

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	60
Key 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
Key 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
Date of first enrolment	01/11/2005
Date of final enrolment	31/07/2006

Oncology Centre

Cambridge
CB2 2QQ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/03/2011		Yes	No
Plain English results				No	Yes

26/10/2018: Cancer Research UK lay results summary link added to Results (plain English)