Randomised trial testing dose escalated intensity modulated radiotherapy in women with higher than average local tumour recurrence risk after breast conservation therapy for early breast cancer
IMPORT HIGH ((Intensity Modulated and Partial Organ Radiotherapy - HIGH)
To test dose escalated intensity modulated radiotherapy after conservation therapy surgery for early breast cancer in women with higher than average local recurrence risk.
Related studies are registered with the following ISRCTNs:
ISRCTN12852634 - IMPORT LOW trial
ISRCTN18654225 - Evaluation of tumour bed localisation and image-guided radiotherapy techniques for breast radiotherapy
As of 15/02/2011 the anticipated start and end dates for this trial have been updated. The previous start and end dates were 01/05/2007 and 01/12/2009 respectively. The new start and end dates are 04/03/2009 and 28/02/2012.
Cambridgeshire 4 Research Ethics Committee on 30/05/2008 (ref: 08/H0305/13)
Prospective randomised controlled clinical trial for patients at higher than average risk of local recurrence.
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
The control arm will have standard dose radiotherapy to the whole breast Monday to Friday for three weeks (15 treatments). This will be followed by a sequential boost dose to the tumour bed Monday to Friday for a further eight treatments. The total number of treatments is 23.
Test arm 1 will have a lower dose of radiotherapy to the area of the breast furthest away from where the tumour used to be, the standard dose of radiotherapy to the area of the breast around where the tumour used to be and a boost dose to the tumour bed. These three treatments will be given simultaneously Monday to Friday for three weeks. The total number of treatments is 15.
Test arm 2 will have the same treatment as test arm 1 but the boost dose to the tumour bed will be higher. Again the total number of treatments is 15.
Primary outcome measure
Palpable induration in the ipsilateral breast.
The primary outcome will be measured at yearly follow up visits by physician examination and also at baseline (before radiotherapy) and at years three and five by photographic assessment years. Outcome from these will be correlated at years three and five.
Secondary outcome measures
1. Quality of life, measured at baseline, six months and years one, three and five
Other secondary outcomes will be measured at annual follow up visits for 10 years and also during the trial by completion of case report forms:
2. Other late adverse effects of radiotherapy in normal tissues
3. Local tumour control
4. Location of tumour relapse in breast
5. Contralateral primary tumours
6. Regional and distant metastases
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Age greater than or equal to 18 years
2. Operable, unilateral breast cancer (T1-3, N0-1, M0 at presentation)
3. Breast conserving surgery
4. Histological confirmation of invasive carcinoma
5. Complete microscopic resection
6. Patient requires a tumour bed boost plus whole breast radiotherapy
7. Written informed consent and availability for follow-up
Target number of participants
Participant exclusion criteria
1. Previous malignancy (other than non-melanomatous skin cancer and Carcinoma In Situ [CIS] of the cervix)
3. Concomitant chemotherapy (sequential chemotherapy allowed)
4. Radiotherapy prescription includes posterior axillary boost field
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Institute of Cancer Research
Institute of Cancer Research (UK)
123 Old Brompton Road
Cancer Research UK (UK) (ref: C1491/A6035)
Funding Body Type
private sector organisation
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
1. 2006 results presented by J. Titley, M.A. Sydenham, J. Mills, J. Haviland, J. Bliss, E. Donovan, K. Venables, J. Yarnold, C. Coles, 'Using dose intensity modulation to test partial volume radiotherapy and dose escalation after conservation surgery for early stage breast cancer the IMPORT Trials' (poster presentation) at National Cancer Research Institute (NCRI) conference 8-11 October 2006 (UK)
2. 2008 results presented at NCRI conference in http://abstracts.ncri.org.uk/abstract/import-high-introduction-of-image-guided-breast-radiotherapy-via-a-national-breast-trial-2/
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
1. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17051947
2. 2007 forward planning analysis in http://www.ncbi.nlm.nih.gov/pubmed/17359764
3. 2011 results in https://www.ncbi.nlm.nih.gov/pubmed/20605349
4. 2014 results in https://www.ncbi.nlm.nih.gov/pubmed/25642565
5. 2015 clinical impact results in https://www.ncbi.nlm.nih.gov/pubmed/26492402
Coles C, Yarnold J, , The IMPORT trials are launched (September 2006)., Clin Oncol (R Coll Radiol), 2006, 18, 8, 587-590.