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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN95889329
Enrollment
1000
Registered
2005-08-17
Start date
2003-01-01
Completion date
Unknown
Last updated
2023-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer Cancer Breast

Interventions

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 ther

Sponsors

University of Edinburgh (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Ipsilateral breast cancer recurrence rates

Secondary

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

Countries

Scotland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 18, 2026