Radiation Therapy and Docetaxel Followed by Standard Therapy in Treating Women With Breast Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in higher doses over a shorter period of time may kill more tumor cells and have fewer side effects. Drugs used in chemotherapy, such as docetaxel, epirubicin, cyclophosphamide, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of radiation therapy when given together with docetaxel followed by standard therapy in treating women with breast cancer.
Drug: epirubicin hydrochloride
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery
Radiation: hypofractionated radiation therapy
Radiation: image-guided radiation therapy
Radiation: radiation therapy
Radiation: stereotactic radiosurgery
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study - Hypofractionated Cyberknife Radiotherapy Combined With Neoadjuvant Chemotherapy for Breast Tumors|
- Maximum-tolerated dose of radiotherapy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2007|
|Study Completion Date:||December 2010|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
|Experimental: Cyberknife||Drug: cyclophosphamide Drug: docetaxel Drug: epirubicin hydrochloride Drug: fluorouracil Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery Radiation: hypofractionated radiation therapy Radiation: image-guided radiation therapy Radiation: radiation therapy Radiation: stereotactic radiosurgery|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00872625
|Centre Antoine Lacassagne|
|Nice, France, 06189|
|Principal Investigator:||Pierre-Yves Bondiau, MD, PhD||Centre Antoine Lacassagne|