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

December 18, 2013 updated by: Medical Research Council

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

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 regimens of radiation therapy following surgery in treating women who have early stage breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 2 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 week for 3 weeks for a total dose of 40 Gy.

A breast boost is recommended in both 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.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 1840 patients (920 per arm) will be accrued for this study.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Carlisle, United Kingdom, CA2 7HY
        • Cumberland Infirmary
      • Portsmouth Hants, United Kingdom, PO3 6AD
        • Saint Mary's Hospital
      • Preston, United Kingdom, PR2 9HT
        • Royal Preston Hospital
    • England
      • Brighton, England, United Kingdom, BN2 5BE
        • Royal Sussex County Hospital
      • Cambridge, England, United Kingdom, CB2 2QQ
        • Addenbrooke's NHS Trust
      • Cheltenham, England, United Kingdom, GL53 7AN
        • Cheltenham General Hospital
      • Exeter, England, United Kingdom, EX2 5DW
        • Royal Devon and Exeter Hospital
      • Guildford, England, United Kingdom, GU2 5XX
        • Royal Surrey County Hospital
      • Ipswich, England, United Kingdom, IP4 5PD
        • Ipswich Hospital NHS Trust
      • Leicester, England, United Kingdom, LE1 5WW
        • University Hospitals of Leicester
      • London, England, United Kingdom, SE1 9RT
        • Guy's and St. Thomas' Hospitals Trust
      • Maidstone, England, United Kingdom, ME16 9QQ
        • Maidstone Hospital
      • Manchester, England, United Kingdom, M20 4BX
        • Christie Hospital N.H.S. Trust
      • Merseyside, England, United Kingdom, L63 4JY
        • Clatterbridge Centre for Oncology NHS Trust
      • Middlesbrough, Cleveland, England, United Kingdom, TS4 3BW
        • South Tees Hospitals NHS Trust
      • Midhurst, England, United Kingdom, GU29 OBL
        • King Edward VII Hospital
      • Northwood, England, United Kingdom, HA6 2RN
        • Mount Vernon Hospital
      • Norwich, England, United Kingdom, NR1 3SR
        • Norfolk & Norwich Hospital
      • Nottingham, England, United Kingdom, NG5 1PB
        • Nottingham City Hospital NHS Trust
      • Plymouth, England, United Kingdom, PL6 8DH
        • Derriford Hospital
      • Reading, England, United Kingdom, RG1 5AN
        • Royal Berkshire Hospital
      • Romford, England, United Kingdom, RM7 OBE
        • Oldchurch Hospital
      • Sheffield, England, United Kingdom, S1O 2SJ
        • Weston Park Hospital
      • Shrewsbury, England, United Kingdom
        • Royal Shrewsbury Hospital
      • Stoke-On-Trent, England, United Kingdom, ST4 7LN
        • North Staffs Royal Infirmary
      • Sutton, England, United Kingdom, SM2 5PT
        • Royal Marsden Hospital
      • Torquay Devon, England, United Kingdom, TQ2 7AA
        • Torbay Hospital
      • Westcliff-On-Sea, England, United Kingdom
        • Southend NHS Trust Hospital
      • Wolverhampton, England, United Kingdom, WV10 0QP
        • New Cross Hospital
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom, BT8 8JR
        • Belfast City Hospital Trust Incorporating Belvoir Park Hospital
    • Scotland
      • Dundee, Scotland, United Kingdom, DD1 9SY
        • Ninewells Hospital and Medical School
    • Wales
      • Cardiff, Wales, United Kingdom, CF4 7XL
        • Velindre Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed invasive unilateral breast cancer

    • 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 is 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Research Council

Investigators

  • Study Chair: John R. Yarnold, MD, FRCR, Royal Marsden NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1999

Study Completion (Actual)

June 1, 2004

Study Registration Dates

First Submitted

May 2, 2000

First Submitted That Met QC Criteria

May 16, 2003

First Posted (Estimate)

May 19, 2003

Study Record Updates

Last Update Posted (Estimate)

December 19, 2013

Last Update Submitted That Met QC Criteria

December 18, 2013

Last Verified

July 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000067661
  • STMG-STARTB
  • EU-99015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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