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

ISRCTN ISRCTN18654225
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

http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-a-new-way-of-locating-the-original-area-of-breast-cancer-after-surgery

Contact information

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

Study information

Study designInterventional trial
Primary study designInterventional
Secondary study designOther
Study setting(s)Hospital
Study typeDiagnostic
Scientific titleEvaluation of tumour bed localisation and image-guided radiotherapy techniques for breast radiotherapy
Study acronymGold Seed Study
Study objectivesDevelop 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) studiedBreast cancer
Intervention1. Imaging investigations (with radiation)
2. Additional portal imaging field and Computed Tomography (CT) scan
3. Insertion of gold breast markers at surgery
Intervention typeOther
Primary outcome measureMean daily displacement in tumour bed centre of gravity expressed as three-dimensional co-ordinates.
Secondary outcome measures1. 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 date01/11/2005
Completion date31/07/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants60
Key inclusion criteria1. 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 criteria1. 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 enrolment01/11/2005
Date of final enrolment31/07/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Oncology Centre
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Cambridge University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

Trust Research & Development
Box 146
Hills road
Cambridge
CB2 2QQ
England
United Kingdom

ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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)