Condition category
Cancer
Date applied
16/02/2007
Date assigned
17/04/2007
Last edited
26/02/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Charlotte Coles

ORCID ID

Contact details

University of Cambridge
Oncology Centre
Box 193
Addenbrooke’s Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00818051

Protocol/serial number

CCR2691

Study information

Scientific title

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

Acronym

IMPORT HIGH ((Intensity Modulated and Partial Organ Radiotherapy - HIGH)

Study hypothesis

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

Ethics approval

Cambridgeshire 4 Research Ethics Committee, 30/05/2008, ref: 08/H0305/13

Study design

Prospective randomised controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Breast cancer

Intervention

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.

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measure

Current primary outcome measure as of 26/02/2019:
Local tumour control measured by reported ipsilateral events at 5 years

Previous primary outcome measure:
Palpable induration in the ipsilateral breast, 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

Current secondary outcome measures as of 26/02/2019:
1. Induration in the ipsilateral breast by clinician assessed changes, patient reported changes, photographic assessments at baseline and 5 years
2. Other late adverse effects in normal tissues reported on CRFs by clinical assessment at 5 years
3. Quality of life reported by patients at baseline, 6 months, 1, 3 and 5 years
4. Location of tumour relapse in breast reported on CRFs and/or assessed by review of scans at 5 years
5. Contralateral primary tumours reported by CRFs at 5 years
6. Regional and distant metastases reported by CRFs at 5 years
7. Survival reported by CRFs at 5 years

Previous secondary outcome measures:
1. Quality of life, measured at baseline, 6 months and years 1, 3 and 5
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
7. Survival

Overall trial start date

04/03/2009

Overall trial end date

16/09/2025

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 26/02/2019:
1. Operable unilateral breast cancer (T1-3, pN0- pN3a, M0 at presentation)
2. Breast conserving surgery
3. Age greater than or equal to 18 years
4. Histological confirmation of invasive carcinoma
5. Complete microscopic resection
6. Patient requires a tumour bed boost plus whole breast radiotherapy for inclusion within the trial
7. Written informed consent and available for follow-up

Previous 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

2568

Total final enrolment

2621

Participant exclusion criteria

Current exclusion criteria as of 26/02/2019:
1. Past history of malignancy except:
1.1. Basal cell skin cancer and CIN cervix uteri or
1.2. Non breast malignancy allowed if treated with curative intent and at least 5 years disease free
2. Mastectomy
3. Concomitant chemotherapy (primary or sequential chemotherapy allowed).
4. Presence of ipsilateral breast implant

Previous exclusion criteria:
1. Previous malignancy (other than non-melanomatous skin cancer and Carcinoma In Situ [CIS] of the cervix)
2. Mastectomy
3. Concomitant chemotherapy (sequential chemotherapy allowed)
4. Radiotherapy prescription includes posterior axillary boost field

Recruitment start date

04/03/2009

Recruitment end date

16/09/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Cancer Research
Sutton
SM2 5PT
United Kingdom

Sponsor information

Organisation

Institute of Cancer Research (UK)

Sponsor details

123 Old Brompton Road
London
SW7 3RP
United Kingdom

Sponsor type

Research organisation

Website

http://www.icr.ac.uk/

Funders

Funder type

Charity

Funder name

Cancer Research UK (UK) (ref: C1491/A16831)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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)

Publication list

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

Publication citations

  1. Coles C, Yarnold J, , The IMPORT trials are launched (September 2006)., Clin Oncol (R Coll Radiol), 2006, 18, 8, 587-590.

Additional files

Editorial Notes

26/02/2019: The following changes were made to the trial record: 1. The recruitment end date was changed from 28/02/2012 to 16/09/2015. 2. The overall trial end date was changed from 28/02/2012 to 16/09/2025. 3. Contact details, primary and secondary outcome measures, inclusion and exclusion criteria updated. 4. The target number of participants was changed from 840 to 2568 and the final enrolment was 2621. 28/09/2018: Publication reference added. 15/02/2011: The 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.