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

Sponsored by:	Federation Nationale des Centres de Lutte Contre le Cancer
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00104702

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 II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Radiation Therapy Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Reproducibility [ 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 [ Designated as safety issue: No ]
Relapse-free survival [ Designated as safety issue: No ]
Overall and specific survival [ Designated as safety issue: No ]
Cosmetic result [ Designated as safety issue: No ]
Direct and indirect costs [ Designated as safety issue: No ]

Estimated Enrollment:	42
Study Start Date:	July 2004
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

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

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

Locations

France
Centre Alexis Vautrin	Recruiting
Vandoeuvre-les-Nancy, France, 54511
Contact: Didier Peiffert, MD 33-3-8359-8434 d.peiffert@nancy.fnclcc.fr
Centre Antoine Lacassagne	Recruiting
Nice, France, 06088
Contact: J. M. Hannoun-Levi, MD 33-4-9203-1260
Centre Hospitalier Lyon Sud	Recruiting
Pierre Benite, France, 69495
Contact: Pascale Romestaing, MD 33-4-78-86-42-51 pascale.romestaing@chu-lyon.fr
Centre Leon Berard	Recruiting
Lyon, France, 69373
Contact: Xavier Montbarbon 33-4-7234-5703
Centre Oscar Lambret	Recruiting
Lille, France, 59020
Contact: Yazid Belkacemi, MD, PhD 33-3-20-29-55-53 y-belkacemi@o-lambret.fr
Institut Gustave Roussy	Recruiting
Villejuif, France, F-94805
Contact: Hugo Marsiglia, MD 33-1-4211-4995 marsiglia@igr.fr
CHU Pitie-Salpetriere	Recruiting
Paris, France, 75651
Contact: Jean-Marc Simon 33-142-178-174
Hopital Saint-Louis	Recruiting
Paris, France, 75475
Contact: Christophe Hennequin, PhD 33-1-4249-4949 christophe.hennequin@sls.ap-hop-paris.fr
Institut Bergonie	Recruiting
Bordeaux, France, 33076
Contact: Laurence Thomas 33-5-5633-3333
Centre Paul Strauss	Recruiting
Strasbourg, France, 67065
Contact: Philippe Quetin 33-3-8825-2478

Sponsors and Collaborators

Federation Nationale des Centres de Lutte Contre le Cancer

Investigators

Investigator:

J. M. Hannoun-Levi, MD

Centre Antoine Lacassagne

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000416123, FRE-FNCLCC-GERICO-03/0303, EU-20501
Study First Received:	March 3, 2005
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00104702 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage I breast cancer
stage II breast cancer

Study placed in the following topic categories:

Skin Diseases
Adjuvants, Immunologic
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009