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A clinical trial testing a 1-week schedule of whole breast radiotherapy against a 3-week schedule

Randomised clinical trial testing a 1-week course of curative whole breast radiotherapy against a standard 3-week schedule in terms of local cancer control and late adverse effects in patients with early breast cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN19906132
Enrollment
4600
Registered
2011-05-31
Start date
2011-09-01
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Breast cancer Cancer Malignant neoplasm of breast

Interventions

Patients will be randomised equally between a standard 3-week schedule and two 1 week test schedules of whole breast radiotherapy Whole breast radiotherapy schedules: Standard group - 40 Gy in 15 fra

Sponsors

Institute of Cancer Research
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Age more than or equal to 18 years 2. Female or male 3. Invasive carcinoma of the breast 4. Breast conservation surgery or mastectomy (reconstruction allowed but not with implant. Tissue expanders with distant metal ports are allowed) 5. Axillary staging and/or dissection 6. Complete microscopic excision of primary tumour 7. Stage pT1-3 pN0-1 M0 disease 8. Written informed consent 9. Able to comply with follow up Concurrent trastuzumab and hormone therapy is allowed

Exclusion criteria

Exclusion criteria: 1. Past history of malignancy except basal cell skin cancer and cervical intraepithelial neoplasia (CIN) or non-breast malignancy allowed if treated with curative intent and at least 5 years disease free 2. Contralateral breast cancer, including ductal carcinoma in-situ (DCIS), irrespective of date of diagnosis 3. Breast reconstruction using implants 4. Concurrent cytotoxic chemotherapy (sequential neoadjuvant or adjuvant cytotoxic therapy allowed) 5. Radiotherapy to any regional lymph node areas (excepting lower axilla included in standard tangential fields to breast/chest wall)

Design outcomes

Primary

MeasureTime frame
Ipsilateral local tumour control: Will be reported at the annual follow up visits. The tests will be performed when the need arises i.e. when the patient feels unwell or reports another lump etc. The tests will be carried out as routine clinical examinations i.e. X rays, computerised tomography (CT) scans, magnetic resonance imaging (MRI), ultrasound.

Secondary

MeasureTime frame
1. Early and late adverse effects in normal tissues 2. Quality of life at baseline, 6, months and 2, 5 and 10 years post randomisation 3. Contralateral primary tumours, regional and distant metastases 4. Survival

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 5, 2026