Radiation Therapy in Treating Older Women Who Are Undergo... | NCT00104702

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2004

Primary Completion Date

Apr 2008Actual

Completion Date

Mar 2011Actual

First Submitted Date

Mar 3, 2005

First Submission Date that Met QC Criteria

Mar 3, 2005

First Posted Date

Mar 4, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 2, 2013

Last Update Posted Date

Sep 4, 2013Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Label	Type	Description	Intervention Names
Concentrated and Focalized Radiotherapy	Experimental		Procedure: adjuvant therapy Procedure: conventional surgery Radiation: radiation therapy

Name	Type	Description	Arm Group Labels	Other Names
adjuvant therapy	Procedure		Concentrated and Focalized Radiotherapy
conventional surgery

Measure	Description	Time Frame
Reproducibility		1 month

Measure	Description	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		3 weeks
Relapse-free survival		1 year

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Type	Description	Link
FRE-FNCLCC-GERICO-03/0303
EU-20501

Facility	Status	City	State	ZIP	Country	Contacts
Institut Bergonie		Bordeaux		33076	France
Centre Oscar Lambret

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D017024	Chemotherapy, Adjuvant
D011878	Radiotherapy

ID	Term
D003131	Combined Modality Therapy
D013812	Therapeutics
D004358	Drug Therapy