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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00104702

Acronym

GERICO03

Enrollment

Registered

2005-03-04

Start date

2004-07-31

Completion date

2011-03-31

Last updated

2013-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

stage I breast cancer, stage II breast cancer

Brief summary

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.

Detailed 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.

Interventions

PROCEDUREadjuvant therapy

PROCEDUREconventional surgery

RADIATIONradiation therapy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

70 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Reproducibility	1 month

Secondary

Measure	Time frame
Impact of localized and concentrated radiotherapy on Katz's Activity of Daily Living score and Lawton's Instrumental Activity of Daily Living score	3 weeks
Relapse-free survival	1 year
Overall and specific survival	1 year
Cosmetic result	1 year
Direct and indirect costs	1 month

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026