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Completed

NCT Number: NCT00107497

Radiation Therapy in Treating Women With Localized Breast Cancer

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

50 year–120 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sussex Cancer Centre at Royal Sussex County Hospital, Brighton, England, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

radiation therapy

Radiation

Primary outcomes

  1. Change in photographic breast appearance

    Time frame: 2 years post randomisation

    Change in photographic breast appearance at 2 years post randomisation compared to a baseline pre-surgical photograph

Sponsors and collaborators

Lead sponsor

Institute of Cancer Research, United Kingdom

Other

Registry information

Official study 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

Acronym: FAST

Important dates

Study start
2004
Primary completion
2007
Study completion
2017
First posted
Apr 6, 2005
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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