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

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: adjuvant therapy; Procedure: conventional surgery; Radiation: radiation therapy

• Registration Number: NCT00104702
• Lead Sponsor: UNICANCER

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.

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2005-03-03
• Study First Submitted QC: 2005-03-03
• Study First Posted: 2005-03-04
• Primary Completion: 2008-04
• Study Completion: 2011-03
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-02
• Last Update Posted: 2013-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Concentrated and Focalized Radiotherapy	adjuvant therapy	-
Concentrated and Focalized Radiotherapy	conventional surgery	-
Concentrated and Focalized Radiotherapy	radiation therapy	-

Primary Outcome Measures

Name	Time	Method
Reproducibility	1 month

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (10)

Centre Antoine Lacassagne; 🇫🇷 Nice, France

Centre Oscar Lambret; 🇫🇷 Lille, 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, France

Institut Bergonie; 🇫🇷 Bordeaux, France

Centre Leon Berard; 🇫🇷 Lyon, France