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 number | NCT00818051 |
| Secondary identifying numbers | CCR2691 |
- Submission date
- 16/02/2007
- Registration date
- 17/04/2007
- Last edited
- 15/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Contact information
Prof 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 randomized controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 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(s) | Cambridgeshire 4 Research Ethics Committee, 30/05/2008, ref: 08/H0305/13 |
| 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 |
| 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 study start date | 23/01/2009 |
| Overall study end date | 16/09/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 2568 |
| Total final enrolment | 2621 |
| 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 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
- 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)
Research organisation
Research organisation
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) (ref: C1491/A16831)
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
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Not provided at time of registration |
| 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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/10/2006 | Yes | No | |
| Other publications | forward planning analysis | 01/04/2007 | Yes | No | |
| Other publications | Trial planning | 15/03/2011 | Yes | 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 | |
| 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 |
| Results article | 08/06/2023 | 12/06/2023 | Yes | No |
Editorial Notes
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.
