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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00104702

First received: March 3, 2005

Last updated: July 9, 2009

Last verified: July 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

March 3, 2005

Last Updated Date

July 9, 2009

Start Date ^ICMJE

July 2004

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Reproducibility [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Reproducibility

Change History

Complete list of historical versions of study NCT00104702 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Impact of localized and concentrated radiotherapy on Katz's Activity of Daily Living score and Lawton's Instrumental Activity of Daily Living score
Relapse-free survival
Overall and specific survival
Cosmetic result
Direct and indirect costs

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Procedure: adjuvant therapy
Procedure: conventional surgery
Radiation: radiation therapy

Study Arm (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

70 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00104702

Other Study ID Numbers ^ICMJE

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

Has Data Monitoring Committee

Responsible Party

Study Sponsor ^ICMJE

UNICANCER

Collaborators ^ICMJE

Investigators ^ICMJE

Investigator:

J. M. Hannoun-Levi, MD

Centre Antoine Lacassagne

Information Provided By

National Cancer Institute (NCI)

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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