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Sponsored by: |
Ontario Clinical Oncology Group (OCOG) |
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Information provided by: | Ontario Clinical Oncology Group (OCOG) |
ClinicalTrials.gov Identifier: | NCT00156052 |
To determine if hypofractionated radiotherapy to the whole breast (4,250 cGy/16 fractions over 22 days) is equally effective to standard fractionated radiotherapy (5,000 cGy/25 fractions over 35 days) in women with node negative breast cancer who have undergone lumpectomy.
The primary outcome is local breast recurrence and secondary outcomes include morbidity and cost effectiveness.
Condition | Intervention | Phase |
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Breast Cancer |
Procedure: Hypofractionated Radiotherapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Trial of Hypofractionated Radiotherapy Post-Lumpectomy in Women With Node Negative Breast Cancer |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
Juravinski Cancer Centre | |
Hamilton, Ontario, Canada, L8V 5C2 | |
Niagara Health System | |
St. Catharines, Ontario, Canada, L2R 5K3 | |
Cancer Centre of Southeastern Ontario at Kingston General Hospital | |
Kingston, Ontario, Canada, K7L 5P9 | |
London Regional Cancer Centre | |
London, Ontario, Canada, N6A 4L6 | |
Ottawa Hospital-Integrated Cancer Program | |
Ottawa, Ontario, Canada, K1H 1C4 | |
The Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5G 2M9 | |
Regional Cancer Care - Thunder Bay HSC | |
Thunder Bay, Ontario, Canada, P7B 6V4 | |
Toronto Sunnybrook Regional Cancer Centre | |
Toronto, Ontario, Canada, M4N 3M5 | |
Windsor Regional Cancer Centre | |
Windsor, Ontario, Canada, N8W 2X3 | |
Regional Cancer Program of the Sudbury Regional Hospital | |
Sudbury, Ontario, Canada, P3E 5J1 | |
Canada, Quebec | |
Montreal General Hospital | |
Montreal, Quebec, Canada, H3G 1A4 |
Study Chair: | Tim Whelan, MD | Juravinski Cancer Centre |
Responsible Party: | Ontario Clinical Oncology Group ( Dr. Mark Levine/Director OCOG ) |
Study ID Numbers: | OCOG-1993-hypo |
Study First Received: | September 8, 2005 |
Last Updated: | July 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00156052 |
Health Authority: | Canada: Health Canada |
Breast Cancer Hypofractionated Radiotherapy Lumpectomy |
Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site |