Randomised trial comparing conventional versus short-course reduced volume conformal post-surgery radiation treatment in women with stage I or II Breast cancer

Completed

• Conditions: Breast cancer; Cancer

• Registration Number: ISRCTN21164902
• Lead Sponsor: niversity Hospital Brussels (Universitair Ziekenhuis Brussel [UZ Brussel]) (Belgium)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-13
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 118

Inclusion Criteria

1. Informed consent
2. Women
3. Age 18 years or older
4. Histologically proven invasive breast carcinoma, stage I or II (T1-3N0 or T1-2N1M0, TNM 6th edition)
5. Surgery with clear margins
6. Pre-operative medical imaging (at least Computed Tomography [CT], Magnetic Resonance Imaging [MRI], and/or Positron Emission Tomography [PET]-scan)

Exclusion Criteria

1. Patients who do not match inclusion criteria
2. Prior breast or thoracic radiotherapy
3. Pregnancy or lactation
4. Fertile patients without effective contraception
5. Psychiatric or addictive disorders

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pulmonary and cardiac toxicities: this will be assessed by respiratory and heart function tests at one to three months after completion of radiotherapy then yearly for three years.

Secondary Outcome Measures

Name	Time	Method
ocal-regional recurrences: this will be assessed at one month after completion of radiotherapy then every three months for three years, then every six months for three years, then yearly thereafter.