Clinical trial NCT00872625: Radiation Therapy and Docetaxel Followed by Standard Therapy in Treating Women With Breast Cancer
Official title: Phase I Study - Hypofractionated Cyberknife Radiotherapy Combined With Neoadjuvant Chemotherapy for Breast Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Keywords: 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
Lead sponsor: Centre Antoine Lacassagne
Sponsor class: OTHER
First posted: 2009-03-31
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximum-tolerated dose of radiotherapy
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Centre Antoine Lacassagne
Study officials:
affiliation: Centre Antoine Lacassagne
name: Pierre-Yves Bondiau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: