Radiation Therapy During Surgery in Treating Older Women With Stage I Breast Cancer (IORT-Sein)

Institut du Cancer de Montpellier - Val d'Aurelle

Status: Completed

Conditions: Breast Cancer

Treatments: Radiation: intraoperative radiation therapy; Procedure: conventional surgery; Procedure: sentinel lymph node biopsy; Procedure: axillary lymph node dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT00556777

CLCC-IORT-Sein

CDR0000574074

INCA-RECF0284

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: Female

Ages: 65 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

treatment arm

Experimental group

Description:

breast conserving surgery with lymph node dissection + Intraoperative radiotherapy

Treatment:

Procedure: axillary lymph node dissection

Procedure: sentinel lymph node biopsy

Procedure: conventional surgery

Radiation: intraoperative radiation therapy