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Spots Global Cancer Trial Database for 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

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Trial Identification

Brief Title: 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

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 ID: NCT00077168

Conditions

Breast Cancer

Study Description

Brief Summary: 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.

Detailed Description: OBJECTIVES: Primary * 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. Secondary * 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.

Eligibility

Minimum Age: 40 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Frenchay Hospital at North Bristol NHS Trust, Bristol, England, United Kingdom

Bristol Haematology and Oncology Centre, Bristol, England, United Kingdom

Broomfield Hospital, Broomefield, England, United Kingdom

Chelmsford and Essex Centre, Chelmsford, England, United Kingdom

Essex County Hospital, Colchester, England, United Kingdom

Derbyshire Royal Infirmary, Derby, England, United Kingdom

Queen's Hospital, Derby, England, United Kingdom

Dorset County Hospital, Dorchester, England, United Kingdom

St. Luke's Cancer Centre at Royal Surrey County Hospital, Guildford, England, United Kingdom

Leeds Cancer Centre at St. James's University Hospital, Leeds, England, United Kingdom

Lincoln County Hospital, Lincoln, England, United Kingdom

Charing Cross Hospital, London, England, United Kingdom

South Manchester University Hospital, Manchester, England, United Kingdom

Clatterbridge Centre for Oncology NHS Trust, Merseyside, England, United Kingdom

Milton Keynes General Hospital, Milton Keynes, England, United Kingdom

Derriford Hospital, Plymouth, England, United Kingdom

Poole Hospital NHS Trust, Poole Dorset, England, United Kingdom

Berkshire Cancer Centre at Royal Berkshire Hospital, Reading, England, United Kingdom

Scarborough General Hospital, Scarborough, England, United Kingdom

University Hospital of North Tees, Stockton-On-Tees, England, United Kingdom

Royal Marsden NHS Foundation Trust - Surrey, Sutton, England, United Kingdom

Torbay Hospital, Torquay Devon, England, United Kingdom

Hillingdon Hospital, Uxbridge, England, United Kingdom

Worcester Royal Hospital, Worcester, England, United Kingdom

Aberdeen Royal Infirmary at NHS Grampian, Aberdeen, Scotland, United Kingdom

Ninewells Hospital, Dundee, Scotland, United Kingdom

University of Glasgow, Glasgow, Scotland, United Kingdom

Ysbyty Gwynedd, Bangor, Wales, United Kingdom

University Hospital of Wales, Cardiff, Wales, United Kingdom

Contact Details

Name: Ronald Kaggwa

Affiliation: Institute of Cancer Research, United Kingdom

Role:

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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