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Phase I Study - Hypofractionated Cyberknife Radiotherapy Combined With Neoadjuvant Chemotherapy for Breast Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Phase I Study - Hypofractionated Cyberknife Radiotherapy Combined With Neoadjuvant Chemotherapy for Breast Tumors


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum-tolerated dose of radiotherapy

Safety Issue:

Yes

Principal Investigator

Pierre-Yves Bondiau, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Antoine Lacassagne

Authority:

Unspecified

Study ID:

CDR0000633331

NCT ID:

NCT00872625

Start Date:

April 2007

Completion Date:

Related Keywords:

  • Breast Cancer
  • 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
  • Breast Neoplasms

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