Randomized Trial Comparing Conventional vs Short-course Reduced Volume Conformal Post-surgery Radiation Treatment in Women With Stage I or II Breast Cancer
Prior to surgery: histological confirmation; medical imaging.
Localizing markers are placed in case of breast conserving surgery.
After surgery, patients are randomized to one of two treatment arms:
- Arm I: radiotherapy using tangential chest fields, and supraclavicular field in case of
nodal involvement, according to our hospital's standard procedure (Voordeckers M et al,
Radiother Oncol 2003;68:227 and 2004;70:225). Dose-fractionation: 50 Gy in 25 fractions
over 5 weeks, 2 Gy/fraction. Additional boost 16 Gy in 8 fractions over 2 weeks if
breast conserving surgery (verify marker/clip localization) and age <= 70 years.
- Arm II: radiotherapy using the Tomotherapy system. Target area (breast, thorax wall,
nodal areas) delimited according to pre-operative imaging and pathological description.
Dose-fractionation (adapted from Whelan T et al, JNCI 2002;94:1143): 42 Gy in 15
fractions over 3 weeks, 2.8 Gy/fraction. Simultaneous boost 0.6 Gy/fraction if breast
Physics quality control is integrated during treatment in both arms.
Radiotherapy begins within 6 weeks after the last breast surgery. Concurrent or sequential
adjuvant systemic treatments are allowed. In case of sequential adjuvant treatment with
chemotherapy first, radiotherapy begins within 6 weeks after completion of the adjuvant
Quality of life, arm mobility and edema, pulmonary and heart function are assessed prior to
radiotherapy, at 1-3 months after completion of radiotherapy, then yearly.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Change from baseline in pulmonary function and heart function tests
Assessment by pulmonary function tests and by heart echocardiography, compared with test values prior to treatment
From end of treatment up to 3 years after treatment
Mark De Ridder, MD, PhD
Radiotherapy Department, Universitair Ziekenhuis Brussel
Belgium: Institutional Review Board