Post-operative Radiotherapy In Minimum-risk Elderly - Phase II

ISRCTN	ISRCTN95889329
DOI	https://doi.org/10.1186/ISRCTN95889329
Protocol serial number	CZH/4/296
Sponsor	University of Edinburgh (UK)
Funders	Robertson Trust, Glasgow. Trial was allowed to use unspent funds from another trial to set up the initial stages of the trial., Chief Scientist Office, Scottish Executive (ref CZH/4/296)

Submission date: 17/06/2005
Registration date: 17/08/2005
Last edited: 16/02/2023

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 of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-radiotherapy-after-surgery-for-women-with-breast-cancer-over-65-years-old

Contact information

Dr Ian Kunkler
Scientific

Edinburgh Cancer Centre
Western General Hospital
Crewe Road
Edinburgh
EH4 2XU
United Kingdom

Phone	+44 (0)131 537 2214
Email	i.kunkler@ed.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Post-operative Radiotherapy In Minimum-risk Elderly - Phase II
Study acronym	PRIME II
Study objectives	To assess the role of post-operative breast radiotherapy in women aged 65 or older, with low risk breast cancer treated by breast conserving surgery and adjuvant endocrine therapy: in particular to estimate the difference in local recurrence rates between patients treated with and without radiotherapy. This trial is related to PRIME I and details in http://www.controlled-trials.com/ISRCTN14817328
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Breast cancer
Intervention	The control arm receive standard breast irradiation (40-50 Gy) over 3-6 weeks and the experimental group receive no breast irradiation. All eligible patients are to receive some form of endocrine therapy.
Intervention type	Other
Primary outcome measure(s)	Ipsilateral breast cancer recurrence rates
Key secondary outcome measure(s)	Regional recurrence, contralateral breast cancer, distant metastases, disease free survival and overall survival
Completion date	30/11/2008

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Female
Target sample size at registration	1000
Total final enrolment	1326
Key inclusion criteria	1. Breast conserving surgery with a complete pathological excision margin of all invasive and non invasive cancer (a minimum of 1 mm on histological assessment) 2. Histologically confirmed unilateral breast cancer of pathological size 3 cm or less 3. Oestrogen receptor or progesterone receptor positive and treated with post-operative adjuvant endocrine therapy (patients who have been treated with pre-operative neo-adjuvant endocrine therapy can be included) 4. No axillary node involvement on histological assessment 5. Medically suitable to attend for all treatment and follow up 6. Able and willing to give informed consent
Key exclusion criteria	1. Age younger than 65 years (date of issue of pathology results) 2. Grade III cancer combined with lymphatic/vascular invasion 3. Previous in situ or invasive carcinoma of either breast 4. Current or previous malignancy, within the past 5 years, other than non-melanomatous skin cancer or carcinoma in situ of cervix
Date of first enrolment	01/01/2003
Date of final enrolment	30/11/2008

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

Edinburgh Cancer Centre

Edinburgh
EH4 2XU
United Kingdom

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2015		Yes	No
Results article		16/02/2023	16/02/2023	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results				No	Yes

Editorial Notes

16/02/2023: Publication reference and total final enrolment added.
17/10/2018: Cancer Research UK lay results summary link added to Results (plain English)