Evaluation of tumour bed localisation and image-guided radiotherapy techniques for breast radiotherapy
ISRCTN | ISRCTN18654225 |
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DOI | https://doi.org/10.1186/ISRCTN18654225 |
Secondary identifying numbers | N/A |
- Submission date
- 04/01/2006
- Registration date
- 03/08/2006
- Last edited
- 26/10/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Dr Charlotte Coles
Scientific
Scientific
Oncology Centre
Box 193
Addenbrookes Hospital
Hills road
Cambridge
CB2 2QQ
United Kingdom
Phone | +44 (0)1223 596182 |
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charlotte.coles@addenbrookes.nhs.uk |
Study information
Study design | Interventional trial |
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Primary study design | Interventional |
Secondary study design | Other |
Study setting(s) | Hospital |
Study type | Diagnostic |
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 | 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 study start date | 01/11/2005 |
Completion date | 31/07/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Oncology Centre
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Sponsor information
Cambridge University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Trust Research & Development
Box 146
Hills road
Cambridge
CB2 2QQ
England
United Kingdom
https://ror.org/04v54gj93 |
Funders
Funder type
Research organisation
West Anglia Cancer Research Network (UK) (for payment of ISRCTN)
No information available
No external funding has been sought, any small additional costs will be funded by participating centres
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Plain English results | No | Yes | |||
Results article | results | 15/03/2011 | Yes | No |
Editorial Notes
26/10/2018: Cancer Research UK lay results summary link added to Results (plain English)