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| ID | Type | Description | Link |
|---|---|---|---|
| CALACASS-CYBERNEO | |||
| CALACASS-2006/24 | |||
| INCA-RECF0621 | |||
| 2006-A00250-51 | Other Identifier | AFSSAPS ID RCB |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyberknife | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyclophosphamide | Drug |
| ||
| docetaxel |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum-tolerated dose of radiotherapy | 6 months |
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DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of breast cancer
No superficial breast cancer (defined as the distance between tumor and skin ≤ 1 cm)
Undergone MRI of the breast to define the macroscopic tumor volume
Undergone scanning of the breast to mark the location for radiotherapy
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre-Yves Bondiau, MD, PhD | Centre Antoine Lacassagne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Antoine Lacassagne | Nice | 06189 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23332384 | Result | Bondiau PY, Courdi A, Bahadoran P, Chamorey E, Queille-Roussel C, Lallement M, Birtwisle-Peyrottes I, Chapellier C, Pacquelet-Cheli S, Ferrero JM. Phase 1 clinical trial of stereotactic body radiation therapy concomitant with neoadjuvant chemotherapy for breast cancer. Int J Radiat Oncol Biol Phys. 2013 Apr 1;85(5):1193-9. doi: 10.1016/j.ijrobp.2012.10.034. Epub 2013 Jan 16. |
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|
| epirubicin hydrochloride | Drug |
|
| fluorouracil | Drug |
|
| neoadjuvant therapy | Procedure |
|
| therapeutic conventional surgery | Procedure |
|
| hypofractionated radiation therapy | Radiation |
|
| image-guided radiation therapy | Radiation |
|
| radiation therapy | Radiation |
|
| stereotactic radiosurgery | Radiation |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D000077143 | Docetaxel |
| D015251 | Epirubicin |
| D005472 | Fluorouracil |
| D020360 | Neoadjuvant Therapy |
| D061089 | Radiotherapy, Image-Guided |
| D011878 | Radiotherapy |
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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