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Completed

NCT Number: NCT00556777

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

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.

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Key information

Conditions

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

Age range

65 year–120 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Montpellier, 34298, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Axillary Lymph Node Dissection

Procedure

conventional surgery

Procedure

Sentinel Lymph Node Biopsy

Procedure

intraoperative radiation therapy

Radiation

Primary outcomes

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

    Time frame: During the treatment of irradiation (4 weeks)

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

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

    Time frame: During the treatment of irradiation (4 weeks)

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

Secondary outcomes

  1. impact on Quality of life of partial irradiation of the breast by per-operative electron therapy

    Time frame: from the baseline to 12 months after the treatment

    Impact described by th scores of "Instrumental Activities of Daily Living scale"

  2. impact on Quality of life of partial irradiation of the breast by per-operative electron therapy

    Time frame: from the baseline to 12 months after the treatment

    Impact described by th scores of "Activities of Daily Living scale"

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

    Time frame: from the baseline to 12 months after the treatment

    Tolerability done with Common Terminology Criteria for Adverse Events scale

  4. Relapse-free survival

    Time frame: from the baseline to 12 months after the treatment

    Relapse-free survival describes with radiologie evaluation

  5. Disease-specific survival

    Time frame: from the baseline to 12 months after the treatment

    Relapse-free survival describes with radiologie evaluation

Sponsors and collaborators

Lead sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Other

Registry information

Official study 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

Acronym: IORT-Sein

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Nov 12, 2007
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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