Clinical trial NCT00104702: Radiation Therapy in Treating Older Women Who Are Undergoing Surgery for Stage I or Stage II Breast Cancer
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: stage I breast cancer
stage II breast cancer
Lead sponsor: UNICANCER
Sponsor class: OTHER
First posted: 2005-03-04
Enrollment: 46
Sex: FEMALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Reproducibility
timeFrame: 1 month
Secondary outcomes:
measure: Impact of localized and concentrated radiotherapy on Katz's Activity of Daily Living score and Lawton's Instrumental Activity of Daily Living score
timeFrame: 3 weeks
measure: Relapse-free survival
timeFrame: 1 year
measure: Overall and specific survival
timeFrame: 1 year
measure: Cosmetic result
timeFrame: 1 year
measure: Direct and indirect costs
timeFrame: 1 month
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonie
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Leon Berard
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Hopital Saint-Louis
city: Paris
country: France
facility: CHU Pitie-Salpetriere
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Vandoeuvre-les-Nancy
country: France
facility: Centre Alexis Vautrin
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Centre Antoine Lacassagne
name: J. M. Hannoun-Levi, MD
role: PRINCIPAL_INVESTIGATOR
References: