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Completed

NCT Number: NCT00104702

Radiation Therapy in Treating Older Women Who Are Undergoing Surgery for Stage I or Stage II Breast Cancer

RATIONALE: Radiation therapy uses high-energy x rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well radiation therapy works in treating older women who are undergoing surgery for stage I or stage II 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

70 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Institut Bergonie, Bordeaux, France

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About this study

OBJECTIVES:

Primary

  • Determine reproducibility of localized and concentrated adjuvant radiotherapy, in terms of isodose curve and dose heterogeneity, in older women with stage I or II breast cancer.

Secondary

  • Determine the impact of this regimen on Katz's Activity of Daily Living score and Lawton's Instrumental Activity of Daily Living score in these patients.
  • Determine relapse-free survival of patients treated with this regimen.
  • Determine overall and specific survival of patients treated with this regimen.
  • Determine the cosmetic result, as assessed by the patient, surgeon, and radiologist, of this regimen in these patients.
  • Determine the direct and indirect costs of this regimen in these patients.

OUTLINE: This is a multicenter, open-label, nonrandomized study.

Patients undergo surgery. After surgery, patients undergo radiotherapy twice daily for 5 days.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

Who can participate

Healthy volunteers accepted: No

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

DISEASE CHARACTERISTICS:

  • Diagnosis of invasive breast cancer
  • Stage I or II disease
  • Tumor size ≤ 30 mm
  • Located in any breast quadrant
  • No nodal involvement
  • No inflammatory breast cancer
  • No positive margins after surgical resection (performed on study)
  • No microcalcifications
  • Hormone receptor status
  • Not specified

PATIENT CHARACTERISTICS:

Age

  • Over 70

Sex

  • Female

Menopausal status

  • Not specified

Performance status

  • Karnofsky 70-100%

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Treatment and study plan

adjuvant therapy

Procedure

conventional surgery

Procedure

radiation therapy

Radiation

Primary outcomes

  1. Reproducibility

    Time frame: 1 month

Secondary outcomes

  1. Impact of localized and concentrated radiotherapy on Katz's Activity of Daily Living score and Lawton's Instrumental Activity of Daily Living score

    Time frame: 3 weeks

  2. Relapse-free survival

    Time frame: 1 year

  3. Overall and specific survival

    Time frame: 1 year

  4. Cosmetic result

    Time frame: 1 year

  5. Direct and indirect costs

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

UNICANCER

Other

Registry information

Official study title

Radio-Surgical Treatment of Breast Cancer of Women Aged Over 70: Phase II Trial of Feasibility and Reproducibility of a Concentrated and Focalized Radiotherapy

Acronym: GERICO03

Important dates

Study start
2004
Primary completion
2008
Study completion
2011
First posted
Mar 4, 2005
Registry last updated
Sep 4, 2013

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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