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Sponsored by: |
Institute of Cancer Research, United Kingdom |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00077168 |
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether radiation therapy after surgery is effective in preventing a recurrence of ductal carcinoma in situ.
PURPOSE: This randomized phase II trial is studying adjuvant radiation therapy to see how well it works compared to observation after surgery in treating women with estrogen receptor positive or progesterone receptor positive ductal carcinoma in situ and are also receiving either tamoxifen or anastrozole.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: anastrozole Drug: tamoxifen citrate Procedure: adjuvant therapy Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Randomised Trial Testing Observation (No Radiotherapy) Against Radiotherapy In Women With Low-Risk Completely Excised ER Positive Ductal Carcinoma In Situ (DCIS) Of The Breast On Adjuvant Endocrine Therapy |
Estimated Enrollment: | 2000 |
Study Start Date: | April 2004 |
Estimated Primary Completion Date: | September 2017 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.
All patients receive adjuvant tamoxifen or anastrozole for 5 years.
Patients are followed every 6 months for 1 year and then annually for up to 10 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 2,000 patients (1,000 per treatment arm) will be accrued for this study within 5 years.
Ages Eligible for Study: | 40 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of unifocal ductal carcinoma in situ of the breast without an invasive component
Planning to receive adjuvant tamoxifen or anastrozole for 5 years
Hormone receptor status:
PATIENT CHARACTERISTICS:
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United Kingdom, England | |
Berkshire Cancer Centre at Royal Berkshire Hospital | |
Reading, England, United Kingdom, RG1 5AN | |
Bristol Haematology and Oncology Centre | |
Bristol, England, United Kingdom, BS2 8ED | |
Broomfield Hospital | |
Broomefield, England, United Kingdom, CM1 7ET | |
Charing Cross Hospital | |
London, England, United Kingdom, W6 8RF | |
Chelmsford and Essex Centre | |
Chelmsford, England, United Kingdom, CM2 0QH | |
Clatterbridge Centre for Oncology NHS Trust | |
Merseyside, England, United Kingdom, CH63 4JY | |
Derbyshire Royal Infirmary | |
Derby, England, United Kingdom, DE1 2QY | |
Lincoln County Hospital | |
Lincoln, England, United Kingdom, LN2 5QY | |
Dorset County Hospital | |
Dorchester, England, United Kingdom, DT1 2JY | |
Essex County Hospital | |
Colchester, England, United Kingdom, C03 3NB | |
Frenchay Hospital at North Bristol NHS Trust | |
Bristol, England, United Kingdom, BS16 1LE | |
Hillingdon Hospital | |
Uxbridge, England, United Kingdom, UB8 3NN | |
Leeds Cancer Centre at St. James's University Hospital | |
Leeds, England, United Kingdom, LS9 7TF | |
Derriford Hospital | |
Plymouth, England, United Kingdom, PL6 8DH | |
Milton Keynes General Hospital | |
Milton Keynes, England, United Kingdom, MK6 5LD | |
Poole Hospital NHS Trust | |
Poole Dorset, England, United Kingdom, BH15 2JB | |
Queen's Hospital | |
Derby, England, United Kingdom, DE1 2QY | |
Royal Marsden NHS Foundation Trust - Surrey | |
Sutton, England, United Kingdom, SM2 5PT | |
Torbay Hospital | |
Torquay Devon, England, United Kingdom, TQ2 7AA | |
South Manchester University Hospital | |
Manchester, England, United Kingdom, M23 9LT | |
St. Luke's Cancer Centre at Royal Surrey County Hospital | |
Guildford, England, United Kingdom, GU2 7XX | |
Scarborough General Hospital | |
Scarborough, England, United Kingdom, YO12 6QL | |
University Hospital of North Tees | |
Stockton-On-Tees, England, United Kingdom, TS19 8PE | |
Worcester Royal Hospital | |
Worcester, England, United Kingdom, WR5 1DD | |
United Kingdom, Scotland | |
Aberdeen Royal Infirmary at NHS Grampian | |
Aberdeen, Scotland, United Kingdom, AB25 2ZN | |
Ninewells Hospital | |
Dundee, Scotland, United Kingdom, DD1 9SY | |
University of Glasgow | |
Glasgow, Scotland, United Kingdom, G11 6NT | |
United Kingdom, Wales | |
University Hospital of Wales | |
Cardiff, Wales, United Kingdom, CF14 4XW | |
Ysbyty Gwynedd | |
Bangor, Wales, United Kingdom, LL57 2PW |
Investigator: | Ronald Kaggwa | Institute of Cancer Research, United Kingdom |
Study ID Numbers: | CDR0000349580, ICR-DCIS-II, EU-20341 |
Study First Received: | February 10, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00077168 |
Health Authority: | United States: Federal Government |
ductal breast carcinoma in situ breast cancer in situ |
Anastrozole Progesterone Skin Diseases Citric Acid Breast Neoplasms Tamoxifen Carcinoma |
Carcinoma, Ductal Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Carcinoma, Ductal, Breast Adenocarcinoma Breast Diseases Neoplasms, Glandular and Epithelial |
Estrogen Antagonists Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors |
Bone Density Conservation Agents Selective Estrogen Receptor Modulators Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses Neoplasms, Ductal, Lobular, and Medullary Aromatase Inhibitors |