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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005587
First received: May 2, 2000
Last updated: December 18, 2013
Last verified: July 2001
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Standardization of Breast Radiotherapy: Trial B - A Randomized Comparison of Fractionation Regimens After Local Excision or Mastectomy in Women With Early Stage Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 1999
Study Completion Date: June 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005587

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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00005587     History of Changes
Other Study ID Numbers: CDR0000067661, STMG-STARTB, EU-99015
Study First Received: May 2, 2000
Last Updated: December 18, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014