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

Breast Cancer Clinical Trial

— GERICO03  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00104702
• Other study ID #: CDR0000416123
• Secondary ID: FRE-FNCLCC-GERIC
• Status: Completed
• Phase: Phase 2
• First received: March 3, 2005
• Last updated: September 2, 2013
• Start date: July 2004
• Est. completion date: March 2011

Study information

• Verified date: September 2013
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: March 2011
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 70 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• adjuvant therapy

• conventional surgery

Radiation:
• radiation therapy

Locations

Country	Name	City	State
France	Institut Bergonie	Bordeaux
France	Centre Oscar Lambret	Lille
France	Centre Leon Berard	Lyon
France	Centre Antoine Lacassagne	Nice
France	CHU Pitie-Salpetriere	Paris
France	Hopital Saint-Louis	Paris
France	Centre Hospitalier Lyon Sud	Pierre Benite
France	Centre Paul Strauss	Strasbourg
France	Centre Alexis Vautrin	Vandoeuvre-les-Nancy
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
UNICANCER

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reproducibility		1 month	No
Secondary	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	No
Secondary	Relapse-free survival		1 year	No
Secondary	Overall and specific survival		1 year	No
Secondary	Cosmetic result		1 year	No
Secondary	Direct and indirect costs		1 month	No