The PRIME Breast Cancer Trial: Postoperative Radiotherapy in Minimum-Risk Elderly

ISRCTN	ISRCTN14817328
DOI	https://doi.org/10.1186/ISRCTN14817328
Secondary identifying numbers	HTA 96/03/01

Submission date: 19/08/2002
Registration date: 19/08/2002
Last edited: 17/10/2018

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

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

Study website

Contact information

Dr Linda Williams
Scientific

PRIME Administrator
Medical Statistics Unit
Medical School
Teviot Place
Edinburgh
EH8 9AG
United Kingdom

Phone	+44 (0)131 651 1631
Email	linda.williams@ed.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The PRIME Breast Cancer Trial: Postoperative Radiotherapy in Minimum-Risk Elderly
Study acronym	PRIME I
Study hypothesis	To assess whether the omission of post-operative radiotherapy in women with low risk axillary node negative breast cancer (T0-2) treated by breast conservation with wide local excision and endocrine therapy: 1. Improves quality of life 2. Is more cost-effective
Ethics approval(s)	Added as of 23/08/2007: Multicentre Research Ethics Committee (MREC) approval was granted by the Scotland Committee on 15 October 1998.
Condition	Breast cancer
Intervention	Please note that, as of 10 January 2008, the anticipated start and end dates of this trial have been updated from 1 September 1999 and 31 December 2003 to 1 January 1999 and 30 November 2005, respectively. Interventions: Patients treated by conservation surgery and adjuvant endocrine therapy will be randomised to receive or not to receive breast irradiation See details of PRIME II trial on http://www.controlled-trials.com/ISRCTN95889329
Intervention type	Other
Primary outcome measure	1. Quality of life assessed by: i. EORTC QLQ-C30 and QLQ-BR23 ii. Philadelphia Geriatric Center Morale Scale iii. EuroQol 2. Anxiety and depression assessed by the Hospital Anxiety and Depression Scale 3. Cost-effectiveness
Secondary outcome measures	1. Loco-regional and distant recurrence rate 2. Functional status assessed by Clackmannan and Barthel scales 3. Acute and late morbidity assessed by the RTOG/EORTC SOMA scale 4. Cosmesis assessed by the Harris scale and the Van Limbergen scale
Overall study start date	01/01/1999
Overall study end date	30/11/2005

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Female
Target number of participants	255 randomised, additional 100 in parallel self-selected cohort
Participant inclusion criteria	1. Age of 65 years or more, receiving adjuvant endocrine therapy 2. Medically suitable to attend for all treatments and follow ups 3. Histologically confirmed unilateral breast cancer of Tumour, Metastasis, Node (TMN) stages T0-2 4. No axillary node involvement on histological assessment 5. Had breast conserving surgery with complete excision on histological assessment 6. Able and willing to give informed consent
Participant exclusion criteria	1. Past history of pure in situ carcinoma of either breast or previous or concurrent malignancy within the past five years other than non-melanomatous skin cancer or carcinoma in situ of cervix 2. Grade III cancer with lymphatic/vascular invasion (because of higher risk of local recurrence)
Recruitment start date	01/01/1999
Recruitment end date	30/11/2005

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

PRIME Administrator

Edinburgh
EH8 9AG
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone	+44 (0)1132 545 843
Email	Sheila.Greener@doh.gsi.gov.uk
Website	http://www.dh.gov.uk/en/index.htm
"ROR"	https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results				No	Yes
Results article	results	01/08/2007		Yes	No

Editorial Notes

17/10/2018: Cancer Research UK lay results summary link added to Results (plain English)