Clinical trial NCT00556777: Radiation Therapy During Surgery in Treating Older Women With Stage I Breast Cancer
Official title: Phase 2 Study Evaluating the Feasibility and the Reproducibility of Concentrated Radiotherapy and Focalized Electrontherapy During Surgery for the Treatment of Older Patients With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: stage I breast cancer
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2007-11-12
Enrollment: 42
Sex: FEMALE
Minimum age (years): 65
Maximum age (years): 120
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Evaluation of feasibility of partial irradiation of the breast by per-operative electron therapy
timeFrame: During the treatment of irradiation (4 weeks)
measure: Evaluation of reproducibility of partial irradiation of the breast by per-operative electron therapy
timeFrame: During the treatment of irradiation (4 weeks)
Secondary outcomes:
measure: impact on Quality of life of partial irradiation of the breast by per-operative electron therapy
timeFrame: from the baseline to 12 months after the treatment
measure: impact on Quality of life of partial irradiation of the breast by per-operative electron therapy
timeFrame: from the baseline to 12 months after the treatment
measure: Tolerability of partial irradiation of the breast by per-operative electron therapy
timeFrame: from the baseline to 12 months after the treatment
measure: Relapse-free survival
timeFrame: from the baseline to 12 months after the treatment
measure: Disease-specific survival
timeFrame: from the baseline to 12 months after the treatment
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Study officials:
affiliation: Institut du Cancer de Montpellier - Val d'Aurelle
name: Jean-Bernard Dubois, MD
role: STUDY_CHAIR
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