Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Prof Charlotte Coles


Study Location:

Skip to Main Content
English | Cymraeg
Be Part of Research - Trial Details - 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

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

Not Recruiting

Open to: Female

Age: Adult

Medical Conditions

Breast cancer


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

04 Mar 2009 16 Sep 2015

Publications

2006 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/17051947 protocol2007 Other publications in https://doi.org/10.1016/j.clon.2007.01.320 forward planning analysis2011 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/20605349 Trial planning2014 Interim results article in https://www.ncbi.nlm.nih.gov/pubmed/25642565 Results of observational sub-study comparing image-guided radiotherapy and standard imaging.2015 Interim results article in https://www.ncbi.nlm.nih.gov/pubmed/26492402 clinical impact results2019 Abstract results in https://doi.org/10.1158/1538-7445.SABCS18-GS4-05 3-year adverse event results presented at San Antonio Breast Cancer Symposium (added 30/12/2022)2021 Abstract results in https://www.estro.org/Congresses/ESTRO-2021/499/profferedpapers16-late-breakingabstracts/3418/importhightrial-doseescalatedsimultaneousintegrate Presented at ESTRO (added 30/12/2022)2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37302395/ (added 12/06/2023)

Interventional

Intervention Type : Other
Intervention Description : 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.




You can take part if:


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 avai


You may not be able to take part if:


Current exclusion criteria as of 26/02/2019:1. Past history of malignancy except:1.1. Basal cell skin cancer and CIN cervix uteri or1.2. Non breast malignancy allowed if treated with curative intent and at least 5 years disease free2. Mastectomy3. 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. Mastectomy3. Concomitant chemotherapy (sequential chemotherapy allowed)4. Radiotherapy prescription includes posterior axillary boost field


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Institute of Cancer Research
    Sutton
    SM2 5PT

This information has not yet been provided by the study team. You'll have an opportunity to discuss any risks and benefits that may be associated with this study prior to consenting to taking part.

Prof Charlotte Coles



The study is sponsored by Institute of Cancer Research (UK) and funded by Cancer Research UK (UK) (ref: C1491/A16831).





We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.


Is this study information helpful?

What will you do next?

Read full details for Trial ID: ISRCTN47437448

Or CPMS 2254

Last updated 15 August 2024

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.