Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Dr Charlotte Coles
ORCID ID
Contact details
Oncology Centre
Box 193
Addenbrookes Hospital
Hills road
Cambridge
CB2 2QQ
United Kingdom
+44 (0)1223 596182
charlotte.coles@addenbrookes.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Gold Seed Study
Study hypothesis
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
Northern and Yorkshire research ethics committee (ref: 05/MRE03/74).
Study design
Interventional trial
Primary study design
Interventional
Secondary study design
Other
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
Mean daily displacement in tumour bed centre of gravity expressed as three-dimensional co-ordinates.
Secondary outcome measures
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
Overall trial start date
01/11/2005
Overall trial end date
31/07/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
60
Participant 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
Recruitment start date
01/11/2005
Recruitment end date
31/07/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Oncology Centre
Cambridge
CB2 2QQ
United Kingdom
Funders
Funder type
Research organisation
Funder name
West Anglia Cancer Research Network (UK) (for payment of ISRCTN)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
No external funding has been sought, any small additional costs will be funded by participating centres
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2011 results in http://www.ncbi.nlm.nih.gov/pubmed/20605349
Publication citations
-
Results
Donovan EM, Ciurlionis L, Fairfoul J, James H, Mayles H, Manktelow S, Raj S, Tsang Y, Tywman N, Yarnold J, Coles C, Planning with intensity-modulated radiotherapy and tomotherapy to modulate dose across breast to reflect recurrence risk (IMPORT High trial)., Int. J. Radiat. Oncol. Biol. Phys., 2011, 79, 4, 1064-1072, doi: 10.1016/j.ijrobp.2009.12.052.