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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UNICANCER
ClinicalTrials.gov Identifier:
NCT00104702
First received: March 3, 2005
Last updated: September 2, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Procedure: adjuvant therapy
Procedure: conventional surgery
Radiation: radiation therapy
Phase 2

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

Resource links provided by NLM:


Further study details as provided by UNICANCER:

Primary Outcome Measures:
  • Reproducibility [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Relapse-free survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Overall and specific survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Cosmetic result [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Direct and indirect costs [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: July 2004
Study Completion Date: March 2011
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Concentrated and Focalized Radiotherapy Procedure: adjuvant therapy Procedure: conventional surgery Radiation: radiation therapy

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

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00104702

Locations
France
Institut Bergonie
Bordeaux, France, 33076
Centre Oscar Lambret
Lille, France, 59020
Centre Leon Berard
Lyon, France, 69373
Centre Antoine Lacassagne
Nice, France, 06088
Hopital Saint-Louis
Paris, France, 75475
CHU Pitie-Salpetriere
Paris, France, 75651
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69495
Centre Paul Strauss
Strasbourg, France, 67065
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, France, 54511
Institut Gustave Roussy
Villejuif, France, F-94805
Sponsors and Collaborators
UNICANCER
Investigators
Principal Investigator: J. M. Hannoun-Levi, MD Centre Antoine Lacassagne
  More Information

No publications provided

Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT00104702     History of Changes
Other Study ID Numbers: CDR0000416123, FRE-FNCLCC-GERICO-03/0303, EU-20501
Study First Received: March 3, 2005
Last Updated: September 2, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by UNICANCER:
stage I breast cancer
stage II breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014