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
- 20/12/2019
- 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
Contact information
Dr Charlotte Coles
Scientific
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 hypothesis | 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 |
| Condition | 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 |
| Overall study end date | 01/10/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 1,935 |
| Total final enrolment | 2018 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/03/2007 |
| Recruitment end date | 05/10/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Institute of Cancer Research
Sutton
SM2 5PT
United Kingdom
SM2 5PT
United Kingdom
Sponsor information
Institute of Cancer Research (UK)
Charity
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
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 | results | 01/02/2019 | 20/12/2019 | Yes | No |
Editorial Notes
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.
