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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
  Purpose

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.


Condition Intervention
Breast Cancer
 Procedure: adjuvant therapy
Radiation: radiation therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

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

Estimated Enrollment: 900
Study Start Date: January 2005
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00107497

Locations
United Kingdom
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, United Kingdom, BN2 5BE
Cumberland Infirmary
Carlisle, England, United Kingdom, CA2 7HY
Cheltenham General Hospital
Cheltenham, England, United Kingdom, GL53 7AN
Royal Devon and Exeter Hospital
Exeter, England, United Kingdom, EX2 5DW
Ipswich Hospital NHS Trust
Ipswich, England, United Kingdom, IP4 5PD
Christie Hospital NHS Trust
Manchester, England, United Kingdom, M20 4BX
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, United Kingdom, CH63 4JY
Berkshire Cancer Centre at Royal Berkshire Hospital
Reading, England, United Kingdom, RG1 5AN
Royal Shrewsbury Hospital
Shrewsbury, England, United Kingdom, SY3 8XQ
University Hospital of North Staffordshire
Stoke-On-Trent, England, United Kingdom, ST4 7LN
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom, SM2 5PT
Torbay Hospital
Torquay Devon, England, United Kingdom, TQ2 7AA
Royal Cornwall Hospital
Truro, Cornwall, England, United Kingdom, TR1 3LJ
Southend University Hospital NHS Foundation Trust
Westcliff-On-Sea, England, United Kingdom, SS0 0RY
Worcester Royal Hospital
Worcester, England, United Kingdom, WR5 1DD
Worthing Hospital
Worthing, England, United Kingdom, BN11 2DH
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, United Kingdom, CF14 2TL
Halton Hospital - North Cheshire Hospitals NHS Trust
Cheshire, United Kingdom, WA7 2DA
Hereford Hospitals NHS Trust
Hereford, United Kingdom, HR1 2ER
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Investigators
Study Chair: John R. Yarnold, MD, FRCR Royal Marsden NHS Foundation Trust
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00107497     History of Changes
Other Study ID Numbers: CDR0000417730, ICR-04/MRE06/17, ICR-FAST, ICR-FAST-04/MRE06/17, EU-20506
Study First Received: April 5, 2005
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013