Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
30/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Linda Williams

ORCID ID

Contact details

PRIME Administrator
Medical Statistics Unit
Medical School
Teviot Place
Edinburgh
EH8 9AG
United Kingdom
+44 (0)131 651 1631
linda.williams@ed.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 96/03/01

Study information

Scientific title

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

Added as of 23/08/2007: Multicentre Research Ethics Committee (MREC) approval was granted by the Scotland Committee on 15 October 1998.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/01/1999

Overall trial end date

30/11/2005

Reason abandoned

Eligibility

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 type

Patient

Age group

Senior

Gender

Female

Target number of participants

255 randomised, additional 100 in parallel self-selected cohort

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

United Kingdom

Trial participating centre

PRIME Administrator
Edinburgh
EH8 9AG
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17669280

Publication citations

  1. Results

    Prescott RJ, Kunkler IH, Williams LJ, King CC, Jack W, van der Pol M, Goh TT, Lindley R, Cairns J, A randomised controlled trial of postoperative radiotherapy following breast-conserving surgery in a minimum-risk older population. The PRIME trial., Health Technol Assess, 2007, 11, 31, 1-149, iii-iv.

Additional files

Editorial Notes