Radiation Therapy in Treating Women With Localized Breast Cancer

Breast Cancer Clinical Trial

— FAST  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00107497
• Other study ID #: CDR0000417730
• Secondary ID: ICR-04/MRE06/17
• Status: Completed
• Phase: N/A
• Start date: October 5, 2004
• Est. completion date: March 9, 2017

Study information

• Verified date: February 2019
• Source: Institute of Cancer Research, United Kingdom
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 917
• Est. completion date: March 9, 2017
• Est. primary completion date: March 9, 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• Radiation therapy

Locations

Country	Name	City	State
United Kingdom	Sussex Cancer Centre at Royal Sussex County Hospital	Brighton	England
United Kingdom	Velindre Cancer Center at Velindre Hospital	Cardiff	Wales
United Kingdom	Cumberland Infirmary	Carlisle	England
United Kingdom	Cheltenham General Hospital	Cheltenham	England
United Kingdom	Halton Hospital - North Cheshire Hospitals NHS Trust	Cheshire
United Kingdom	Royal Devon and Exeter Hospital	Exeter	England
United Kingdom	Hereford Hospitals NHS Trust	Hereford
United Kingdom	Ipswich Hospital NHS Trust	Ipswich	England
United Kingdom	Christie Hospital NHS Trust	Manchester	England
United Kingdom	Clatterbridge Centre for Oncology NHS Trust	Merseyside	England
United Kingdom	Berkshire Cancer Centre at Royal Berkshire Hospital	Reading	England
United Kingdom	Royal Shrewsbury Hospital	Shrewsbury	England
United Kingdom	University Hospital of North Staffordshire	Stoke-On-Trent	England
United Kingdom	Royal Marsden NHS Foundation Trust - Surrey	Sutton	England
United Kingdom	Torbay Hospital	Torquay Devon	England
United Kingdom	Royal Cornwall Hospital	Truro, Cornwall	England
United Kingdom	Southend University Hospital NHS Foundation Trust	Westcliff-On-Sea	England
United Kingdom	Worcester Royal Hospital	Worcester	England
United Kingdom	Worthing Hospital	Worthing	England

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Cancer Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in photographic breast appearance	Change in photographic breast appearance at 2 years post randomisation compared to a baseline pre-surgical photograph	2 years post randomisation

External Links

•   First results of the randomised UK FAST Trial of radiotherapy hypofractionation for treatment of early breast cancer (CRUKE/04/015), Radiotherapy and Oncology, Volume 100, Issue 1, 2011, Pages 93 - 100