Condition category
Cancer
Date applied
04/01/2006
Date assigned
03/08/2006
Last edited
22/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

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

Sponsor type

Government

Website

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

Results - basic reporting

Publication summary

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

Publication citations

  1. 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.

Additional files

Editorial Notes