Radiation Therapy in Treating Women With Localized Breast Cancer

NCT00107497 | Completed DMC

• 2 other identifiers: CDR0000417730ICR-04/MRE06/17
• Study Type: interventional
• Target: 917
• Locations: 1 country
• Sites: 19

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.

Conditions

Breast Cancer

Keywords

stage I breast cancer; stage II breast cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Control

ACTIVE COMPARATOR

50Gy in 25 fractions of radiation therapy over 5 weeks

Radiation: Radiation therapy

Test group 1

ACTIVE COMPARATOR

30Gy in 5 fractions of radiation therapy over 5 weeks

Radiation: Radiation therapy

Test group 2

ACTIVE COMPARATOR

28.5Gy in 5 fractions of radiation therapy over 5 weeks

Radiation: Radiation therapy

Interventions

Radiation therapy RADIATION

Control; Test group 1; Test group 2

Eligibility Criteria

• Age: 50 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Institute of Cancer Research, United Kingdom: lead

Study Sites (19)

Sussex Cancer Centre at Royal Sussex County Hospital

Brighton, England, BN2 5BE, United Kingdom

Location

Cumberland Infirmary

Carlisle, England, CA2 7HY, United Kingdom

Location

Cheltenham General Hospital

Cheltenham, England, GL53 7AN, United Kingdom

Location

Royal Devon and Exeter Hospital

Exeter, England, EX2 5DW, United Kingdom

Location

Ipswich Hospital NHS Trust

Ipswich, England, IP4 5PD, United Kingdom

Location

Christie Hospital NHS Trust

Manchester, England, M20 4BX, United Kingdom

Location

Clatterbridge Centre for Oncology NHS Trust

Merseyside, England, CH63 4JY, United Kingdom

Location

Berkshire Cancer Centre at Royal Berkshire Hospital

Reading, England, RG1 5AN, United Kingdom

Location

Royal Shrewsbury Hospital

Shrewsbury, England, SY3 8XQ, United Kingdom

Location

University Hospital of North Staffordshire

Stoke-on-Trent, England, ST4 7LN, United Kingdom

Location

Royal Marsden NHS Foundation Trust - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Torbay Hospital

Torquay Devon, England, TQ2 7AA, United Kingdom

Location

Royal Cornwall Hospital

Truro, Cornwall, England, TR1 3LJ, United Kingdom

Location

Southend University Hospital NHS Foundation Trust

Westcliff-on-Sea, England, SS0 0RY, United Kingdom

Location

Worcester Royal Hospital

Worcester, England, WR5 1DD, United Kingdom

Location

Worthing Hospital

Worthing, England, BN11 2DH, United Kingdom

Location

Velindre Cancer Center at Velindre Hospital

Cardiff, Wales, CF14 2TL, United Kingdom

Location

Halton Hospital - North Cheshire Hospitals NHS Trust

Cheshire, WA7 2DA, United Kingdom

Location

Hereford Hospitals NHS Trust

Hereford, HR1 2ER, United Kingdom

Location

Related Publications (1)

• Brunt AM, Haviland JS, Sydenham M, Agrawal RK, Algurafi H, Alhasso A, Barrett-Lee P, Bliss P, Bloomfield D, Bowen J, Donovan E, Goodman A, Harnett A, Hogg M, Kumar S, Passant H, Quigley M, Sherwin L, Stewart A, Syndikus I, Tremlett J, Tsang Y, Venables K, Wheatley D, Bliss JM, Yarnold JR. Ten-Year Results of FAST: A Randomized Controlled Trial of 5-Fraction Whole-Breast Radiotherapy for Early Breast Cancer. J Clin Oncol. 2020 Oct 1;38(28):3261-3272. doi: 10.1200/JCO.19.02750. Epub 2020 Jul 14.

  PMID: 32663119 DERIVED

Related 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

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• John R. Yarnold, MD, FRCR

  Royal Marsden NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2005
• First Posted: April 6, 2005
• Study Start: October 5, 2004
• Primary Completion: March 9, 2007
• Study Completion: March 9, 2017
• Last Updated: February 27, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (19)