Breast Cancer
Conditions
Keywords
stage I breast cancer
Brief summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving intraoperative radiation therapy may reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well giving radiation therapy during surgery works in treating older women with stage I breast cancer.
Detailed description
OBJECTIVES: Primary * Study the feasibility and reproducibility of intraoperative radiotherapy as the only treatment after lumpectomy in older women with stage I breast cancer. Secondary * Study the impact of this regimen on maintaining self-care. * Study the quality of life (QLQ-C30) and satisfaction with care. * Study regimen tolerance and cosmetic results. * Evaluate the economic impact of this treatment. * Study relapse-free and disease-specific survival. OUTLINE: Patients undergo conservative breast surgery and axillary node dissection (sentinel node or classic resection). At this point, patients must have either negative axillary lymph nodes after removal of ≥ 6 lymph nodes, negative sentinel nodes, or have had a limited lumpectomy with negative margins ≥ 2 mm. Patients undergo intraoperative radiotherapy during surgery, before closing and reconstruction of the breast. Patients may begin hormonal therapy after completing study therapy. After completion of study therapy, patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.
Interventions
PROCEDUREaxillary lymph node dissection
PROCEDUREconventional surgery
PROCEDUREsentinel lymph node biopsy
RADIATIONintraoperative radiation therapy
Sponsors
Institut du Cancer de Montpellier - Val d'Aurelle
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
partial irradiation of the breast, after an enlarged tumorectomy and negative sentinel limph node, assessing the feasibility and technical reproducibility of a per-concentrated irradiationThe first treatment was a surgical operation focused on the initial tumor area as the only treatment
Eligibility
Sex/Gender
FEMALE
Age
65 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: Inclusion criteria: * Histologically confirmed stage I breast cancer * Size ≤ 20 mm (by ultrasound), N0, any quadrant * Hormone receptor status not specified
Exclusion criteria
* Distant metastases * Inflammatory breast cancer * Lobular in situ disease * Invasive cancer or ductal carcinoma in situ * Nonepithelial disease or sarcoma * Multicentric disease * Lymphatic embolism * Margins of safety unknown or positive (in situ or invasive) * Preoperative mammography showing diffuse microcalcification PATIENT CHARACTERISTICS: * Female * Menopausal * Karnofsky 70-100% * No other prior cancer except basal cell skin cancer, uterine epithelioma in situ, or other cancer in complete remission for the past 5 years * No geographic, social, or psychiatric reasons that would impede participation in study treatment PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior neoadjuvant therapy * No concurrent participation in another study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of feasibility of partial irradiation of the breast by per-operative electron therapy | During the treatment of irradiation (4 weeks) | feasibility based on dosimetric criteria based on the Quality Index of the application. |
| Evaluation of reproducibility of partial irradiation of the breast by per-operative electron therapy | During the treatment of irradiation (4 weeks) | reproducibility based on dosimetric criteria based on the Quality Index of the application. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| impact on Quality of life of partial irradiation of the breast by per-operative electron therapy | from the baseline to 12 months after the treatment | Impact described by th scores of Instrumental Activities of Daily Living scale |
| Tolerability of partial irradiation of the breast by per-operative electron therapy | from the baseline to 12 months after the treatment | Tolerability done with Common Terminology Criteria for Adverse Events scale |
| Relapse-free survival | from the baseline to 12 months after the treatment | Relapse-free survival describes with radiologie evaluation |
| Disease-specific survival | from the baseline to 12 months after the treatment | Relapse-free survival describes with radiologie evaluation |
Countries
France
Outcome results
None listed