Condition category
Cancer
Date applied
17/06/2005
Date assigned
17/08/2005
Last edited
02/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Ian Kunkler

ORCID ID

Contact details

Edinburgh Cancer Centre
Western General Hospital
Crewe Road
Edinburgh
EH4 2XU
United Kingdom
+44 (0)131 537 2214
i.kunkler@ed.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CZH/4/296

Study information

Scientific title

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

Acronym

PRIME II

Study hypothesis

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

Not provided at time of registration

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

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

Phase

Not Specified

Drug names

Primary outcome measures

Ipsilateral breast cancer recurrence rates

Secondary outcome measures

Regional recurrence, contralateral breast cancer, distant metastases, disease free survival and overall survival

Overall trial start date

01/01/2003

Overall trial end date

30/11/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Female

Target number of participants

1000

Participant 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

Recruitment start date

01/01/2003

Recruitment end date

30/11/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Edinburgh Cancer Centre
Edinburgh
EH4 2XU
United Kingdom

Sponsor information

Organisation

University of Edinburgh (UK)

Sponsor details

Old College
South Bridge
Edinburgh
EH8 9YL
United Kingdom
+44 (0)131 650 1000
communications.office@ed.ac.uk

Sponsor type

University/education

Website

http://www.ed.ac.uk/

Funders

Funder type

Charity

Funder name

Robertson Trust, Glasgow. Trial was allowed to use unspent funds from another trial to set up the initial stages of the trial.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Chief Scientist Office, Scottish Executive (ref CZH/4/296)

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

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25637340

Publication citations

Additional files

Editorial Notes