A clinical trial testing a one week schedule of whole breast radiotherapy against a three week schedule

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2011
INTERVENTION: 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 ‐ 40Gy in 15 fractions over 15 days (not weekends) Test group 1 ‐ 27Gy in 5 fractions over 5 days (not weekends) Test group 2 ‐ 26Gy in 5 fractions over 5 days (not weekends) Patients will be followed up for a minimum of 10 years. There are Quality of Life and a photographic sub‐studies, each with 2196 patients. Quality of Life questionnaires will be completed at baseline, 6, months and 2, 5 and 10 years post randomisation. Photographs will be taken at baseline and 2, 5 and 10 years post randomisation. CONDITION: Breast cancer ; Cancer ; Malignant neoplasm of breast PRIMARY OUTCOME: 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 OUTCOME: 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 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
Epistemonikos ID: f37c4378d2590d76a0b7afcdba9086266f30ad73
First added on: Aug 22, 2024