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

ISRCTN	ISRCTN47437448
DOI	https://doi.org/10.1186/ISRCTN47437448
ClinicalTrials.gov (NCT)	NCT00818051
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	CCR2691
Sponsor	Institute of Cancer Research (UK)
Funder	Cancer Research UK (UK) (ref: C1491/A16831)

Submission date: 16/02/2007
Registration date: 17/04/2007
Last edited: 28/07/2025

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://www.cancerhelp.org.uk/trials/a-trial-comparing-different-ways-of-giving-radiotherapy-for-early-stage-breast-cancer

Contact information

Prof Charlotte Coles
Scientific

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

Study information

Primary study design	Interventional
Study design	Prospective randomized controlled clinical trial
Secondary study design	Randomised controlled trial
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
Study acronym	IMPORT HIGH (Intensity Modulated and Partial Organ Radiotherapy - HIGH)
Study objectives	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(s)	Cambridgeshire 4 Research Ethics Committee, 30/05/2008, ref: 08/H0305/13
Health condition(s) or problem(s) studied	Breast cancer
Intervention	The control arm will have standard dose radiotherapy to the whole breast Monday to Friday for 3 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
Primary outcome measure(s)	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 3 and 5 by photographic assessment years. Outcome from these will be correlated at years 3 and 5.
Key secondary outcome measure(s)	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
Completion date	16/09/2025

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	2568
Total final enrolment	2621
Key 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
Key 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
Date of first enrolment	04/03/2009
Date of final enrolment	16/09/2015

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Institute of Cancer Research

Sutton
SM2 5PT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from the IMPORT Trial Team (import-icrctsu@icr.ac.uk). De-identified individual participant data, together with a data dictionary defining each field in the set, will be made available to other researchers on request from the time of publication. There is no time limit on applying for this data. Trial documentation including the protocol are available online. The ICR-CTSU supports wider dissemination of information from the research it conducts and increased cooperation between investigators. Trial data are obtained, managed, stored, shared, and archived according to ICR-CTSU standard operating procedures to ensure the enduring quality, integrity, and utility of the data. Formal requests for data sharing are considered in line with ICR-CTSU procedures, with due regard given to funder and sponsor guidelines. Requests are via a standard proforma describing the nature of the proposed research and the extent of data requirements. Data recipients are required to enter a formal data-sharing agreement, which describes the conditions for release and requirements for data transfer, storage, archiving, publication, and intellectual property. Requests are reviewed by the trial management group in terms of scientific merit and ethical considerations, including patients’ consent. Data sharing is undertaken if proposed projects have a sound scientific or patients’ benefit rationale, as agreed by the trial management group and approved by the independent data monitoring and steering committee, as required. Restrictions relating to patients’ confidentiality and consent will be limited by aggregating and anonymising identifiable patients’ data. Additionally, all indirect identifiers that could lead to deductive disclosures will be removed in line with ICR-CTSU data-sharing guidelines.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		08/06/2023	12/06/2023	Yes	No
Results article	5-year trends and baseline predictors of patient-reported adverse events	23/07/2025	28/07/2025	Yes	No
Protocol article		01/10/2006		Yes	No
Abstract results	3-year adverse event results presented at San Antonio Breast Cancer Symposium	15/02/2019	30/12/2022	No	No
Abstract results	Presented at ESTRO	29/08/2021	30/12/2022	No	No
Interim results article	Results of observational sub-study comparing image-guided radiotherapy and standard imaging.	01/11/2014		Yes	No
Interim results article	Clinical impact results	01/03/2015		Yes	No
Other publications	Forward planning analysis	01/04/2007		Yes	No
Other publications	Trial planning	15/03/2011		Yes	No

Editorial Notes

28/07/2025: Publication reference added.
15/08/2024: IPD sharing plan added.
31/07/2024: Contact details updated.
29/07/2024: The contact was updated.
12/06/2023: Publication reference added.
30/12/2022: The following changes have been made:
1. The overall trial start date was changed from 04/03/2009 to 23/01/2009.
2. Abstract references added.
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.