Randomised trial testing Intensity Modulated radiotherapy and Partial Organ RadioTherapy following breast conservation surgery for early breast cancer

ISRCTN	ISRCTN12852634
DOI	https://doi.org/10.1186/ISRCTN12852634
ClinicalTrials.gov number	NCT00814567
Secondary identifying numbers	CCR2690

Submission date: 11/07/2006
Registration date: 28/07/2006
Last edited: 16/06/2025

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.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-comparing-different-ways-of-giving-radiotherapy-for-low-risk-early-stage-breast-cancer

Contact information

Dr Charlotte Coles
Scientific

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

Study information

Study design	Prospective randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Randomised trial testing Intensity Modulated radiotherapy and Partial Organ RadioTherapy following breast conservation surgery for early breast cancer
Study acronym	IMPORT LOW
Study objectives	To test partial breast radiotherapy delivered using intensity modulated techniques following complete local tumour excision of low risk early stage breast cancer. A related study IMPORT HIGH is registered with ISRCTN47437448.
Ethics approval(s)	Oxford Research Ethics Committee B, 12/10/2006, ref: 06/Q1605/128
Health condition(s) or problem(s) studied	Breast cancer
Intervention	This is a randomised controlled trial for patients at low risk of local recurrence (less than 1% annual risk local recurrence after radiotherapy). Control group: current standard radiotherapy to the whole breast Test arm one: reduced radiotherapy to the whole breast with standard radiotherapy to the partial breast Test arm two: standard radiotherapy to the partial breast only
Intervention type	Other
Primary outcome measure	Local tumour control in the ipsilateral breast
Secondary outcome measures	1. Location of tumour relapse 2. Contralateral primary tumours 3. Regional and distant metastases 4. Late adverse effects in normal tissues 5. Quality of life (QL) 6. Economic evaluation
Overall study start date	01/03/2007
Completion date	01/10/2020

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	1,935
Total final enrolment	2018
Key inclusion criteria	Current inclusion criteria as of 26/02/2019: 1. Age greater than or equal to 50 years 2. Primary breast conservation surgery +/- adjuvant systemic therapy 3. Pathological tumour size  3.0 cm pT1-2 (< 3.1 cm, maximum microscopic diameter of invasive component) 4. Invasive adenocarcinoma (excluding invasive carcinoma of classical lobular type) 5. Unifocal disease 6. Grade I, II or III 7. Lymphovascular invasion present or absent 8. Axillary lymph nodes negative or 1 to 3 nodes positive (pN0 or pN+(1-3)) 9. Minimum microscopic margin of non-cancerous tissue  2 mm (excluding deep margin if this is at deep fascia) 10. No blood-borne metastases Previous inclusion criteria: 1. Age greater than or equal to 50 years 2. Primary breast conservation surgery +/- adjuvant systemic therapy 3. Pathological tumour size less than or equal to 2.0 cm pT1a-c (maximum microscopic diameter of invasive component) 4. Invasive adenocarcinoma (excluding invasive carcinoma of classical lobular type) 5. Unifocal disease (Grade I or II) 6. Minimum microscopic margin of non-cancerous tissue greater than or equal to 2 mm (excluding deep margin if this is at deep fascia) 7. No lympho-vascular invasion 8. Axillary lymph nodes negative, PN0 (sentinel node biopsy & isolated tumour cells less than 0.2 mm allowed) 9. No blood borne metastases
Key exclusion criteria	Current exclusion criteria as of 26/02/2019: 1. Previous malignancy (other than non-melanomatous skin cancer) 2. Mastectomy 3. Invasive carcinoma of classical lobular type 4. Primary endocrine therapy or chemotherapy (neo-adjuvant endocrine therapy is permissible as long as the tumour is <3.0 cm and all other inclusion criteria are met. Primary endocrine therapy as a replacement for surgery is not permissible) 5. Concurrent chemo-radiotherapy Previous exclusion criteria: 1. Previous malignancy (other than non-melanomatous skin cancer) 2. Mastectomy 3. Invasive carcinoma of classical lobular type 4. Primary endocrine therapy or chemotherapy (neo-adjuvant endocrine therapy is permissible as long as the tumour is less than 2.0 cm and all other inclusion criteria are met. Primary endocrine therapy as a replacement for surgery is not permissible) 5. Concurrent chemo-radiotherapy
Date of first enrolment	01/03/2007
Date of final enrolment	05/10/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Institute of Cancer Research

Sutton
SM2 5PT
United Kingdom

Sponsor information

Institute of Cancer Research (UK)
Charity

123 Old Brompton Road
London
SW7 3RP
United Kingdom

Website	http://www.icr.ac.uk
"ROR"	https://ror.org/043jzw605

Funders

Funder type

Charity

Cancer Research UK (UK)
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

Department of Health (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	09/09/2017		Yes	No
Results article	Patient-reported outcome measures substudy at 5 years	01/02/2019	20/12/2019	Yes	No
Results article	10-year outcomes were analysed in the intention-to-treat population	11/06/2025	16/06/2025	Yes	No

Editorial Notes

16/06/2025: Publication reference added.
20/12/2019: Publication reference added.
14/11/2019: The following changes have been made:
1. The recruitment end date has been changed from 01/10/2019 to 05/10/2010.
2. The final enrolment number has been added.
26/02/2019: The following changes were made to the trial record:
1. The overall trial end date was changed from 01/10/2019 to 01/10/2020.
2. Contact details, inclusion and exclusion criteria updated.
09/08/2017: Internal review.
03/08/2017: Publication reference added.