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| Sponsor: | Medical Research Council |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005587 |
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 III |
| 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 |
| Study Start Date: | January 1999 |
OBJECTIVES:
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.
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 |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive unilateral breast cancer
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and 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 | |
| Study Chair: | John R. Yarnold, MD, FRCR | Royal Marsden NHS Foundation Trust |
More Information
| ClinicalTrials.gov Identifier: | NCT00005587 History of Changes |
| Other Study ID Numbers: | CDR0000067661, STMG-STARTB, EU-99015 |
| Study First Received: | May 2, 2000 |
| Last Updated: | February 12, 2010 |
| Health Authority: | United States: Federal Government |
|
stage I breast cancer stage II breast cancer stage IIIA breast cancer |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
