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


Phase 2
70 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Reproducibility

Safety Issue:

No

Principal Investigator

J. M. Hannoun-Levi, MD

Investigator Affiliation:

Centre Antoine Lacassagne

Authority:

United States: Federal Government

Study ID:

CDR0000416123

NCT ID:

NCT00104702

Start Date:

July 2004

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • Breast Neoplasms

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