- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00872625
Radiation Therapy and Docetaxel Followed by Standard Therapy in Treating Women With Breast Cancer
Phase I Study - Hypofractionated Cyberknife Radiotherapy Combined With Neoadjuvant Chemotherapy for Breast Tumors
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.
Study Overview
Status
Conditions
Intervention / Treatment
- Drug: cyclophosphamide
- Drug: docetaxel
- Drug: fluorouracil
- Radiation: radiation therapy
- Procedure: therapeutic conventional surgery
- Procedure: neoadjuvant therapy
- Drug: epirubicin hydrochloride
- Radiation: stereotactic radiosurgery
- Radiation: hypofractionated radiation therapy
- Radiation: image-guided radiation therapy
Detailed Description
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Nice, France, 06189
- Centre Antoine Lacassagne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of breast cancer
- Unifocal disease
- Non-metastatic disease
- Not a candidate for breast-conserving surgery
- 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:
- WHO performance status 0-2
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 6 months after completion of study treatment
- No counter-indications to surgery, standard neoadjuvant chemotherapy, or insertion of an implantable venous device
- No patient for whom clinical follow up is impossible for psychological, familial, social, or geographical reasons
- No patients deprived of liberty or under trusteeship
PRIOR CONCURRENT THERAPY:
- No prior ipsilateral breast irradiation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cyberknife
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum-tolerated dose of radiotherapy
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Docetaxel
- Cyclophosphamide
- Fluorouracil
- Epirubicin
Other Study ID Numbers
- CDR0000633331
- CALACASS-CYBERNEO
- CALACASS-2006/24
- INCA-RECF0621
- EUDRACT-2006-A00250-51
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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