Radiation Therapy in Treating Older Women Who Are Undergoing Surgery for Stage I or Stage II Breast Cancer (GERICO03)

Unicancer

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Procedure: adjuvant therapy; Radiation: radiation therapy; Procedure: conventional surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT00104702

CDR0000416123

FRE-FNCLCC-GERICO-03/0303

EU-20501

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 46 patients

Sex: Female

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

Concentrated and Focalized Radiotherapy

Experimental group

Treatment:

Procedure: conventional surgery

Procedure: adjuvant therapy

Radiation: radiation therapy