Adjuvant Radiation Therapy Compared With Observation After Surgery in Treating Women With Estrogen Receptor Positive or Progesterone Receptor Positive Ductal Carcinoma In Situ of the Breast Who Are Receiving Tamoxifen or Anastrozole
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00077168|
Recruitment Status : Unknown
Verified October 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : February 11, 2004
Last Update Posted : February 9, 2009
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 or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: anastrozole Drug: tamoxifen citrate Procedure: adjuvant therapy Radiation: radiation therapy||Phase 2|
- Compare ipsilateral tumor relapse and breast cancer metastases in women with completely excised low-risk estrogen receptor- or progesterone receptor-positive ductal carcinoma in situ of the breast receiving adjuvant tamoxifen or anastrozole and treated with adjuvant radiotherapy vs observation alone.
- Compare the quality of life of patients treated with these regimens.
- Determine the minimal surgical margins required to minimize the local recurrence rate in patients treated with these regimens.
- Identify molecular markers that predict ipsilateral tumor recurrence in patients treated with these regimens.
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.
- Arm I: Patients undergo radiotherapy 5 days a week for 3 or 5 weeks.
- Arm II: Patients undergo observation alone. Quality of life is assessed at baseline, at 6 months, and then at 1, 2, and 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|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|
|Study Start Date :||April 2004|
|Estimated Primary Completion Date :||September 2017|
- Local tumor control (invasive and in situ local recurrence)
- Mastectomy rate
- Pattern of relapse in the breast
- Contralateral primary
- Breast cancer metastases
- Quality of life
- Molecular markers that predict ipsilateral tumor recurrence
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00077168
|Frenchay Hospital at North Bristol NHS Trust|
|Bristol, England, United Kingdom, BS16 1LE|
|Bristol Haematology and Oncology Centre|
|Bristol, England, United Kingdom, BS2 8ED|
|Broomefield, England, United Kingdom, CM1 7ET|
|Chelmsford and Essex Centre|
|Chelmsford, England, United Kingdom, CM2 0QH|
|Essex County Hospital|
|Colchester, England, United Kingdom, C03 3NB|
|Derbyshire Royal Infirmary|
|Derby, England, United Kingdom, DE1 2QY|
|Derby, England, United Kingdom, DE1 2QY|
|Dorset County Hospital|
|Dorchester, England, United Kingdom, DT1 2JY|
|St. Luke's Cancer Centre at Royal Surrey County Hospital|
|Guildford, England, United Kingdom, GU2 7XX|
|Leeds Cancer Centre at St. James's University Hospital|
|Leeds, England, United Kingdom, LS9 7TF|
|Lincoln County Hospital|
|Lincoln, England, United Kingdom, LN2 5QY|
|Charing Cross Hospital|
|London, England, United Kingdom, W6 8RF|
|South Manchester University Hospital|
|Manchester, England, United Kingdom, M23 9LT|
|Clatterbridge Centre for Oncology NHS Trust|
|Merseyside, England, United Kingdom, CH63 4JY|
|Milton Keynes General Hospital|
|Milton Keynes, England, United Kingdom, MK6 5LD|
|Plymouth, England, United Kingdom, PL6 8DH|
|Poole Hospital NHS Trust|
|Poole Dorset, England, United Kingdom, BH15 2JB|
|Berkshire Cancer Centre at Royal Berkshire Hospital|
|Reading, England, United Kingdom, RG1 5AN|
|Scarborough General Hospital|
|Scarborough, England, United Kingdom, YO12 6QL|
|University Hospital of North Tees|
|Stockton-On-Tees, England, United Kingdom, TS19 8PE|
|Royal Marsden NHS Foundation Trust - Surrey|
|Sutton, England, United Kingdom, SM2 5PT|
|Torquay Devon, England, United Kingdom, TQ2 7AA|
|Uxbridge, England, United Kingdom, UB8 3NN|
|Worcester Royal Hospital|
|Worcester, England, United Kingdom, WR5 1DD|
|Aberdeen Royal Infirmary at NHS Grampian|
|Aberdeen, Scotland, United Kingdom, AB25 2ZN|
|Dundee, Scotland, United Kingdom, DD1 9SY|
|University of Glasgow|
|Glasgow, Scotland, United Kingdom, G11 6NT|
|Bangor, Wales, United Kingdom, LL57 2PW|
|University Hospital of Wales|
|Cardiff, Wales, United Kingdom, CF14 4XW|
|OverallOfficial:||Ronald Kaggwa||Institute of Cancer Research, United Kingdom|