Radiation Therapy in Treating Older Women Who Are Undergoing Surgery for Stage I or Stage II Breast Cancer (GERICO03)

September 2, 2013 updated by: UNICANCER

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • Institut Bergonie
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Lyon, France, 69373
        • Centre Léon Bérard
      • Nice, France, 06088
        • Centre Antoine Lacassagne
      • Paris, France, 75651
        • CHU Pitié-Salpétrière
      • Paris, France, 75475
        • Hôpital Saint-Louis
      • Pierre Benite, France, 69495
        • Centre Hospitalier LYON SUD
      • Strasbourg, France, 67065
        • Centre Paul Strauss
      • Vandoeuvre-les-Nancy, France, 54511
        • Centre Alexis Vautrin
      • Villejuif, France, F-94805
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Concentrated and Focalized Radiotherapy
Radiation: radiation therapy
Procedure: adjuvant therapy
Procedure: conventional surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reproducibility
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome 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
Time Frame: 3 weeks
3 weeks
Relapse-free survival
Time Frame: 1 year
1 year
Overall and specific survival
Time Frame: 1 year
1 year
Cosmetic result
Time Frame: 1 year
1 year
Direct and indirect costs
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNICANCER

Investigators

  • Principal Investigator: J. M. Hannoun-Levi, MD, Centre Antoine Lacassagne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

March 3, 2005

First Submitted That Met QC Criteria

March 3, 2005

First Posted (Estimate)

March 4, 2005

Study Record Updates

Last Update Posted (Estimate)

September 4, 2013

Last Update Submitted That Met QC Criteria

September 2, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000416123
  • FRE-FNCLCC-GERICO-03/0303
  • EU-20501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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