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

NCT ID: NCT00556777

Last Updated: 2025-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-19

Study Completion Date

2008-12-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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treatment arm

breast conserving surgery with lymph node dissection + Intraoperative radiotherapy

Group Type EXPERIMENTAL

axillary lymph node dissection

Intervention Type PROCEDURE

conventional surgery

Intervention Type PROCEDURE

sentinel lymph node biopsy

Intervention Type PROCEDURE

intraoperative radiation therapy

Intervention Type RADIATION

Interventions

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axillary lymph node dissection

Intervention Type PROCEDURE

conventional surgery

Intervention Type PROCEDURE

sentinel lymph node biopsy

Intervention Type PROCEDURE

intraoperative radiation therapy

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

120 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Institut du Cancer de Montpellier - Val d'Aurelle

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Bernard Dubois, MD

Role: STUDY_CHAIR

Institut du Cancer de Montpellier - Val d'Aurelle

Locations

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Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, , France

Site Status

Countries

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France

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Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CLCC-IORT-Sein

Identifier Type: -

Identifier Source: secondary_id

INCA-RECF0284

Identifier Type: -

Identifier Source: secondary_id

CDR0000574074

Identifier Type: -

Identifier Source: org_study_id

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