Radiation Therapy in Treating Women With Localized Breast Cancer

This study has been completed.

Sponsor:

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00107497

First received: April 5, 2005

Last updated: February 6, 2009

Last verified: May 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

April 5, 2005

Last Updated Date

February 6, 2009

Start Date ^ICMJE

January 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00107497 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Radiation Therapy in Treating Women With Localized Breast Cancer

Official Title ^ICMJE

Prospective Randomised Clinical Trial Testing 5.7 Gy and 6.0 Gy Fractions of Whole Breast Radiotherapy in Terms of Late Normal Tissue Responses and Tumour Control - FAST

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways and giving it after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This randomized clinical trial is studying radiation therapy to see how well it works in treating women with localized breast cancer.

Detailed Description

OBJECTIVES:

Compare late normal tissue effects of standard vs 2 different dose levels of hypofractionated adjuvant whole breast radiotherapy, in terms of changes in photographic breast appearance, in women with localized breast cancer who are at average or low risk of recurrence.
Compare tumor control in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 3 treatment arms.

Arm I (control): Patients undergo standard radiotherapy 5 days a week for 5 weeks.
Arm II: Patients undergo hypofractional radiotherapy once a week for 5 weeks.
Arm III: Patients undergo hypofractional radiotherapy (at a lower dose than arm II) once a week for 5 weeks.

After completion of study treatment, patients are followed annually for 5-10 years.

PROJECTED ACCRUAL: A total of 900 patients (300 per treatment arm) will be accrued for this study within 12 months.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Primary Purpose: Treatment

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Procedure: adjuvant therapy
Radiation: radiation therapy

Study Arm (s)

Not Provided

Publications *

Not Provided

* 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

Completed

Estimated Enrollment ^ICMJE

900

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

Diagnosis of invasive carcinoma of the breast
- Localized disease
  - Pathological tumor size < 3.0 cm in diameter
  - Axillary node negative
At average or low risk of local tumor recurrence
Must have undergone prior breast-preserving surgery
- No prior mastectomy
- Complete microscopic resection of tumor
Hormone receptor status:
- Not specified

PATIENT CHARACTERISTICS:

Age

50 and over

Sex

Female

Menopausal status

Not specified

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Other

Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No prior neoadjuvant or adjuvant cytotoxic chemotherapy

Endocrine therapy

Not specified

Radiotherapy

No concurrent lymphatic radiotherapy
No concurrent radiotherapy boost to the breast

Surgery

See Disease Characteristics

Gender

Female

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00107497

Other Study ID Numbers ^ICMJE

CDR0000417730, ICR-04/MRE06/17, ICR-FAST, ICR-FAST-04/MRE06/17, EU-20506

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Institute of Cancer Research, United Kingdom

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

John R. Yarnold, MD, FRCR

Royal Marsden NHS Foundation Trust

Information Provided By

National Cancer Institute (NCI)

Verification Date

May 2007

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

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