Phase I Study - Hypofractionated Cyberknife Radiotherapy Combined With Neoadjuvant Chemotherapy for Breast Tumors
- Evaluate the tolerance to concurrent neoadjuvant docetaxel and cyberknife
hypofractionated radiotherapy followed by standard treatment in women with breast
cancer in order to find the maximum-tolerated dose of radiotherapy.
- Evaluate the efficacy of the combination chemoradiotherapy.
- Evaluate breast-conserving surgery.
- Evaluate the quality of life.
OUTLINE: This is a dose-escalation study of cyberknife hypofractionated radiotherapy.
Patients receive neoadjuvant docetaxel IV on day 1. Treatment repeats every 3 weeks for up
to 3 courses in the absence of disease progression or unacceptable toxicity. Beginning
during the first or second course of neoadjuvant chemotherapy, patients undergo
hypofractionated radiotherapy. Patients then receive standard chemotherapy comprising
epirubicin hydrochloride IV, cyclophosphamide IV, and fluorouracil IV on day 1. Treatment
repeats every 3 weeks for up to 3 courses in the absence of disease progression or
unacceptable toxicity. Patients undergo surgery 4-8 weeks after the last course of
chemotherapy, and then undergo standard radiotherapy.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Maximum-tolerated dose of radiotherapy
Pierre-Yves Bondiau, MD, PhD
Centre Antoine Lacassagne