Radiation Therapy After Surgery in Treating Women With Early Stage Breast Cancer

Breast Cancer Clinical Trial

Official title:

Standardization of Breast Radiotherapy: Trial A - A Randomized Comparison of Fractionation Regimens After Local Excision or Mastectomy in Women With Early Stage Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005588
• Other study ID #: CDR0000067662
• Secondary ID: STMG-STARTAEU-99
• Status: Completed
• Phase: Phase 3
• First received: May 2, 2000
• Last updated: December 18, 2013
• Start date: January 1999
• Est. completion date: December 2004

Study information

• Verified date: June 2000
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of radiation therapy is more effective following surgery for breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of radiation therapy following surgery in treating women who have early stage breast cancer.

Description:

OBJECTIVES:

• Determine the benefits of radiotherapy schedules using fraction sizes larger than 2.0 Gy in terms of normal tissue responses, local-regional tumor control, quality of life, and economic consequences in women prescribed postoperative radiotherapy for early stage breast cancer.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, type of surgery (mastectomy vs local excision), and breast boost (yes vs no). Patients are randomized to 1 of 3 treatment arms.

• Arm I: Patients receive radiotherapy 5 times a week for 5 weeks for a total dose of 50 Gy.

• Arm II: Patients receive radiotherapy 5 times a fortnight (i.e., Monday/Wednesday/Friday/Tuesday/Thursday/Monday, etc.) for 13 fractions over 5 weeks for a total dose of 41.6 Gy.

• Arm III: Patients receive radiotherapy as in arm II for a total dose of 39 Gy. A breast boost is recommended in all arms for patients with microscopic evidence of invasive or in situ cancer at, or within 1 mm of, a resection margin. These patients receive radiotherapy for 5 fractions in 1 week for a total boost dose of 10 Gy.

Quality of life is assessed at baseline and then at 6, 12, 24, and 60 months.

Patients are followed annually for up to 20 years.

PROJECTED ACCRUAL: A total of 2,010 patients (670 per arm) will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed invasive unilateral breast cancer that is considered operable

• T1-3, N0-1, M0 at presentation

• Complete macroscopic excision of tumor by breast conserving surgery or mastectomy

• No immediate breast reconstruction

• No requirement for axillary radiotherapy after greater than a Level 1 axillary dissection or after greater than 10 lymph nodes have been removed

• Not enrolled on SECRAB or OSCAR trials

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age:

• 18 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

PRIOR CONCURRENT THERAPY:

• Prior neoadjuvant, or primary medical, therapy allowed provided subsequent surgery confirms complete macroscopic excision of residual primary tumor

Biologic therapy:

• Not specified

Chemotherapy:

• At least 2 weeks since prior cytotoxic agents

• No concurrent chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

Surgery:

• See Disease Characteristics

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United Kingdom	Belfast City Hospital Trust Incorporating Belvoir Park Hospital	Belfast	Northern Ireland
United Kingdom	Royal Sussex County Hospital	Brighton	England
United Kingdom	Addenbrooke's NHS Trust	Cambridge	England
United Kingdom	Velindre Hospital	Cardiff	Wales
United Kingdom	Cumberland Infirmary	Carlisle
United Kingdom	Cheltenham General Hospital	Cheltenham	England
United Kingdom	Ninewells Hospital and Medical School	Dundee	Scotland
United Kingdom	Royal Devon and Exeter Hospital	Exeter	England
United Kingdom	Royal Surrey County Hospital	Guildford	England
United Kingdom	Ipswich Hospital NHS Trust	Ipswich	England
United Kingdom	University Hospitals of Leicester	Leicester	England
United Kingdom	Guy's and St. Thomas' Hospitals Trust	London	England
United Kingdom	Maidstone Hospital	Maidstone	England
United Kingdom	Christie Hospital N.H.S. Trust	Manchester	England
United Kingdom	Clatterbridge Centre for Oncology NHS Trust	Merseyside	England
United Kingdom	South Tees Hospitals NHS Trust	Middlesbrough, Cleveland	England
United Kingdom	King Edward VII Hospital	Midhurst	England
United Kingdom	Mount Vernon Hospital	Northwood	England
United Kingdom	Norfolk & Norwich Hospital	Norwich	England
United Kingdom	Nottingham City Hospital NHS Trust	Nottingham	England
United Kingdom	Derriford Hospital	Plymouth	England
United Kingdom	Saint Mary's Hospital	Portsmouth Hants
United Kingdom	Royal Preston Hospital	Preston
United Kingdom	Royal Berkshire Hospital	Reading	England
United Kingdom	Oldchurch Hospital	Romford	England
United Kingdom	Weston Park Hospital	Sheffield	England
United Kingdom	Royal Shrewsbury Hospital	Shrewsbury	England
United Kingdom	North Staffs Royal Infirmary	Stoke-On-Trent	England
United Kingdom	Royal Marsden Hospital	Sutton	England
United Kingdom	Torbay Hospital	Torquay Devon	England
United Kingdom	Southend NHS Trust Hospital	Westcliff-On-Sea	England
United Kingdom	New Cross Hospital	Wolverhampton	England

Sponsors (1)

Lead Sponsor	Collaborator
Medical Research Council

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

Hopwood P, Haviland J, Mills J, Sumo G, M Bliss J; START Trial Management Group. The impact of age and clinical factors on quality of life in early breast cancer: an analysis of 2208 women recruited to the UK START Trial (Standardisation of Breast Radioth — View Citation

Hopwood P, Haviland JS, Sumo G, Mills J, Bliss JM, Yarnold JR; START Trial Management Group. Comparison of patient-reported breast, arm, and shoulder symptoms and body image after radiotherapy for early breast cancer: 5-year follow-up in the randomised St — View Citation

Venables K, Miles EA, Aird EG, Hoskin PJ; START Trial Management Group. The use of in vivo thermoluminescent dosimeters in the quality assurance programme for the START breast fractionation trial. Radiother Oncol. 2004 Jun;71(3):303-10. — View Citation