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17 May 2012
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| [ Print-friendly version ] |
| The PRIME Breast Cancer Trial: Postoperative Radiotherapy in Minimum-Risk Elderly |
| ISRCTN | ISRCTN14817328 |
| ClinicalTrials.gov identifier | |
| Public title | The PRIME Breast Cancer Trial: Postoperative Radiotherapy in Minimum-Risk Elderly |
| Scientific title | |
| Acronym | PRIME I |
| Serial number at source | HTA 96/03/01 |
| 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 |
| Lay summary | |
| 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 |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Breast cancer |
| Participants - 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 |
| Participants - 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) |
| Anticipated start date | 01/01/1999 |
| Anticipated end date | 30/11/2005 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 255 randomised, additional 100 in parallel self-selected cohort |
| Interventions |
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 |
| Primary outcome measure(s) |
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 measure(s) |
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 |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Trial website | http://homepages.ed.ac.uk/prime/prime.html |
| Publications | 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17669280 |
| Contact name | Dr Linda Williams |
| Address |
PRIME Administrator
Medical Statistics Unit Medical School Teviot Place |
| City/town | Edinburgh |
| Zip/Postcode | EH8 9AG |
| Country | United Kingdom |
| Tel | +44 (0)131 651 1631 |
| Fax | +44 (0)131 651 1631 |
| linda.williams@ed.ac.uk | |
| Sponsor | Department of Health (UK) |
| Address |
Quarry House
Quarry Hill |
| City/town | Leeds |
| Zip/Postcode | LS2 7UE |
| Country | United Kingdom |
| Tel | +44 (0)1132 545 843 |
| Sheila.Greener@doh.gsi.gov.uk | |
| Sponsor website: | http://www.dh.gov.uk/en/index.htm |
| Date applied | 19/08/2002 |
| Last edited | 21/08/2009 |
| Date ISRCTN assigned | 19/08/2002 |
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| © 2012 ISRCTN unless otherwise stated. | |
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