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

NCT00556777 | Completed

• 3 other identifiers: CDR0000574074CLCC-IORT-SeinINCA-RECF0284
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

stage I breast cancer

Outcome Measures

Primary Outcomes (2)

• Evaluation of feasibility of partial irradiation of the breast by per-operative electron therapy

  feasibility based on dosimetric criteria based on the Quality Index of the application.

  During the treatment of irradiation (4 weeks)

• Evaluation of reproducibility of partial irradiation of the breast by per-operative electron therapy

  reproducibility based on dosimetric criteria based on the Quality Index of the application.

  During the treatment of irradiation (4 weeks)

Secondary Outcomes (5)

• 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 on Quality of life of partial irradiation of the breast by per-operative electron therapy

  from the baseline to 12 months after the treatment

• Tolerability of partial irradiation of the breast by per-operative electron therapy

  from the baseline to 12 months after the treatment

• Relapse-free survival

  from the baseline to 12 months after the treatment

• Disease-specific survival

  from the baseline to 12 months after the treatment

Study Arms (1)

treatment arm

EXPERIMENTAL

breast conserving surgery with lymph node dissection + Intraoperative radiotherapy

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

Interventions

axillary lymph node dissection PROCEDURE

treatment arm

conventional surgery PROCEDURE

treatment arm

sentinel lymph node biopsy PROCEDURE

treatment arm

intraoperative radiation therapy RADIATION

treatment arm

Eligibility Criteria

• Age: 65 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Histologically confirmed stage I breast cancer
• Size ≤ 20 mm (by ultrasound), N0, any quadrant
• Hormone receptor status not specified

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

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

Montpellier, 34298, France

Location

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MeSH Terms

Conditions

Breast Neoplasms

Interventions

Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques

Study Officials

• Jean-Bernard Dubois, MD

  Institut du Cancer de Montpellier - Val d'Aurelle

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 9, 2007
• First Posted: November 12, 2007
• Study Start: April 19, 2004
• Primary Completion: December 31, 2008
• Study Completion: December 31, 2008
• Last Updated: March 6, 2025

Record last verified: 2025-03

Locations

FR (1)