NCT00104702

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started Jul 2004

Longer than P75 for phase_2 breast-cancer

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2005

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

September 4, 2013

Status Verified

September 1, 2013

Enrollment Period

3.8 years

First QC Date

March 3, 2005

Last Update Submit

September 2, 2013

Conditions

Breast Cancer

Keywords

stage I breast cancerstage II breast cancer

Outcome Measures

Primary Outcomes (1)

  • Reproducibility

    1 month

Secondary Outcomes (5)

  • 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

Study Arms (1)

Concentrated and Focalized Radiotherapy

EXPERIMENTAL
Procedure: adjuvant therapyProcedure: conventional surgeryRadiation: radiation therapy

Interventions

adjuvant therapyPROCEDURE
Concentrated and Focalized Radiotherapy
conventional surgeryPROCEDURE
Concentrated and Focalized Radiotherapy
radiation therapyRADIATION
Concentrated and Focalized Radiotherapy

Eligibility Criteria

Age70 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (10)

Institut Bergonie

Bordeaux, 33076, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Centre Antoine Lacassagne

Nice, 06088, France

Location

Hopital Saint-Louis

Paris, 75475, France

Location

CHU Pitie-Salpetriere

Paris, 75651, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Centre Paul Strauss

Strasbourg, 67065, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Chemotherapy, AdjuvantRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • J. M. Hannoun-Levi, MD

    Centre Antoine Lacassagne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2005

First Posted

March 4, 2005

Study Start

July 1, 2004

Primary Completion

April 1, 2008

Study Completion

March 1, 2011

Last Updated

September 4, 2013

Record last verified: 2013-09

Locations

FR(10)