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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN21164902

Enrollment

118

Registered

2007-04-13

Start date

2007-05-01

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 eligible for adjuvant post-surgery radiotherapy are randomised between treatment by conventional radiotherapy (control arm) and treatment with Tomotherapy (experimental arm). Arm I (control,

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Local-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.	—

Countries

Belgium

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026