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
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Dr Charlotte Coles
Scientific

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

Study design	Interventional, phase III, randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronym	Cambridge IMRT
Study hypothesis	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
Condition	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	Breast shrinkage following radiotherapy
Secondary outcome measures	1. Acute skin reactions 2. Clinical assessment of late cosmetic effect 3. Patients quality of life
Overall study start date	01/04/2003
Overall study end date	31/03/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	375
Participant 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
Participant 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
Recruitment start date	01/04/2003
Recruitment end date	31/03/2006

Oncology Centre

Cambridge
CB2 2QQ
United Kingdom

Cambridge University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

Trust Research and Development Department
Box 146
Addenbrookes Hospital
Hills road
Cambridge
CB2 2QQ
England
United Kingdom

"ROR"	https://ror.org/04v54gj93

Charity

Breast Cancer Campaign (London), grant reference number 2001:263 (UK)

No information available

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

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