A Randomised Controlled Trial: Investigation of Radiotherapy Dose Inhomogeneity and Cosmetic Outcome in Patients with Early Breast Cancer

ISRCTN	ISRCTN21474421
DOI	https://doi.org/10.1186/ISRCTN21474421
Protocol serial number	N/A
Sponsor	Cambridge University Hospitals NHS Foundation Trust (UK)
Funder	Breast Cancer Campaign (London), grant reference number 2001:263 (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Dr Charlotte Coles
Scientific

Oncology Centre
Box 193
Addenbrooke's Hospital
Hills road
Cambridge
CB2 2QQ
United Kingdom

Primary study design	Interventional
Study design	Interventional, phase III, randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	Cambridge IMRT
Study objectives	Does correction of dose homogeneity improve the cosmetic outcome following radiotherapy in patients with early breast cancer?
Ethics approval(s)	Approved by the Cambridge Reseach Ethics Committee on 04/02/03, reference number 03/017
Health condition(s) or problem(s) studied	Breast Cancer
Intervention	Patients are randomised to receive Intensity Modulated Radiation therapy (IMRT). Control group will receive standard 2-dimensional radiation therapy.
Intervention type	Other
Primary outcome measure(s)	Breast shrinkage following radiotherapy
Key secondary outcome measure(s)	1. Acute skin reactions 2. Clinical assessment of late cosmetic effect 3. Patients quality of life
Completion date	31/03/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	375
Key inclusion criteria	1. Age 18 years and above 2. Operable unilateral breast cancer (T1-3, N0-1, M0 at presentation) 3. Histological confirmation of invasive carcinoma 4. Complete macroscopic excision of tumour by breast conserving surgery 5. No history of contralateral breast cancer 6. Demonstration of off-axis dose inhomogeneities outside -5% and +7% of the prescribed dose using conventional 2-dimensional radiotherapy treatment plan 7. Patients consents to be part of the trial and availability for follow-up
Key exclusion criteria	1. Patients with advance or metastatic breast cancer 2. Patients who have had a mastectomy 3. Patients with bilateral breast cancer 4. Concomitant invasive malignancy (apart from Cervical Intra-epithelial Neoplasia [CIN] III uterine cervix and basal carcinoma of the skin), if other previous malignancies, must be disease-free for five years
Date of first enrolment	01/04/2003
Date of final enrolment	31/03/2006

Oncology Centre

Cambridge
CB2 2QQ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	baseline characteristics and dosimetry results	01/07/2009		Yes	No
Other publications	prospective analysis study	01/01/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes