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

Completed

• Conditions: Cancer; Breast Cancer

• Registration Number: ISRCTN21474421
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-17
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 375

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified