Radiation Therapy and Docetaxel Followed by Standard Therapy in Treating Women With Breast Cancer
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
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 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized 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 [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 18 |
| Study Start Date: | April 2007 |
| Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| France | |
| Centre Antoine Lacassagne | Recruiting |
| Nice, France, 06189 | |
| Contact: Pierre-Yves Bondiau, MD, PhD 33-4-9203-1261 | |
| Principal Investigator: | Pierre-Yves Bondiau, MD, PhD | Centre Antoine Lacassagne |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00872625 History of Changes |
| Other Study ID Numbers: | CDR0000633331, CALACASS-CYBERNEO, CALACASS-2006/24, INCA-RECF0621, EUDRACT-2006-A00250-51 |
| Study First Received: | March 28, 2009 |
| Last Updated: | January 7, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
stage IA breast cancer stage IB breast cancer stage II breast cancer stage IIIA breast cancer |
stage IIIB breast cancer stage IIIC breast cancer recurrent breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Cyclophosphamide Fluorouracil Docetaxel Epirubicin Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Antimetabolites Antimetabolites, Antineoplastic |
ClinicalTrials.gov processed this record on May 21, 2013