Trial Information

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
conserving surgery.

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
chemotherapy.

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.