Radiation Therapy During Surgery in Treating Older Women With Stage I Breast Cancer

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00556777
• Other study ID #: CDR0000574074
• Secondary ID: CLCC-IORT-SeinIN
• Status: Completed
• Phase: Phase 2
• First received: November 9, 2007
• Last updated: May 12, 2011
• Start date: January 2004

Study information

• Verified date: December 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• axillary lymph node dissection

• conventional surgery

• sentinel lymph node biopsy

Radiation:
• intraoperative radiation therapy

Locations

Country	Name	City	State
France	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility			No
Primary	Reproducibility			No
Secondary	Quality of life (QLQ-C30)			No
Secondary	Satisfaction with care			No
Secondary	Tolerability			Yes
Secondary	Cosmetic results			No
Secondary	Economic impact			No
Secondary	Relapse-free survival			No
Secondary	Disease-specific survival			No