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A Randomised Controlled Trial: Investigation of Radiotherapy Dose Inhomogeneity and Cosmetic Outcome in Patients with Early Breast Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN21474421
Enrollment
375
Registered
2006-02-17
Start date
2003-04-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Breast Cancer Cancer Breast Cancer

Interventions

Patients are randomised to receive Intensity Modulated Radiation therapy (IMRT). Control group will receive standard 2-dimensional radiation therapy.

Sponsors

Cambridge University Hospitals NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Age 18 years and above 2. Operable unilateral breast cancer (T1-3, N0-1, M0 at presentation) 3. Histological confirmation of invasive carcinoma 4. Complete macroscopic excision of tumour by breast conserving surgery 5. No history of contralateral breast cancer 6. Demonstration of off-axis dose inhomogeneities outside -5% and +7% of the prescribed dose using conventional 2-dimensional radiotherapy treatment plan 7. Patients? consents to be part of the trial and availability for follow-up

Exclusion criteria

Exclusion criteria: 1. Patients with advance or metastatic breast cancer 2. Patients who have had a mastectomy 3. Patients with bilateral breast cancer 4. Concomitant invasive malignancy (apart from Cervical Intra-epithelial Neoplasia [CIN] III uterine cervix and basal carcinoma of the skin), if other previous malignancies, must be disease-free for five years

Design outcomes

Primary

MeasureTime frame
Breast shrinkage following radiotherapy

Secondary

MeasureTime frame
1. Acute skin reactions 2. Clinical assessment of late cosmetic effect 3. Patient?s quality of life

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 27, 2026