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Sponsors and Collaborators: |
Ontario Clinical Oncology Group (OCOG) Canadian Breast Cancer Research Alliance |
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Information provided by: | Ontario Clinical Oncology Group (OCOG) |
ClinicalTrials.gov Identifier: | NCT00156130 |
This study is evaluating the long-term outcomes of women in a randomized trial that compared accelerated whole breast irradiation (42.5 Gy in 16 fractions over 22 days) to a longer conventional schedule of whole breast irradiation (50 Gy in 25 fractions over 35 days) following breast-conserving surgery. The outcomes evaluated will include cosmetic outcome and cardiac disease as a measure of late radiation morbidity and local breast recurrence as a measure of effectiveness.
Condition | Intervention | Phase |
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Breast Cancer |
Radiation: Conventional radiotherapy schedule Radiation: Accelarated radiotherapy schedule |
Phase IV |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Accelerated Radiotherapy Outcomes in Women (Long Term Outcomes of a Randomized Trial of Breast Irradiation Schedules After Lumpectomy in Women With Node-Negative Breast Cancer)(AROW) |
Estimated Enrollment: | 1234 |
Study Start Date: | October 2003 |
Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
Accelerated whole breast irradiation
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Radiation: Accelarated radiotherapy schedule
42.5 Gy in 16 fractions over 22 days
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2
Conventional whole breast irradiation
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Radiation: Conventional radiotherapy schedule
50 Gy in 25 fractions over 35 days
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This study is evaluating the long-term outcomes of women in a randomized trial that compared accelerated whole breast irradiation (42.5 Gy in 16 fractions over 22 days) to a longer conventional schedule of whole breast irradiation (50 Gy in 25 fractions over 35 days) following breast-conserving surgery. The results reported at 5 years demonstrated equivalence for these two different radiation schedules for the effect of local recurrence in the breast and cosmetic outcome. Emerging data has suggested that accelerated or shorter radiation schedules may potentially be associated with an increased risk of late morbidity of the skin, soft tissue and the heart at 10 years and beyond. The purpose of this study is to evaluate the long term outcomes of women randomized in the trial. The outcomes evaluated will include cosmetic outcome and cardiac disease as a measure of late radiation morbidity and local breast recurrence as a measure of effectiveness.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Extended long term follow-up of patients recruited into the "Randomized Trial of Hypofractionated Radiotherapy Post-Lumpectomy in Women with Node Negative Breast Cancer" study.
Only patients recruited into the "Randomized Trial of Hypofractionated Radiotherapy Post-Lumpectomy in Women with Node Negative Breast Cancer" study are eligible to be enrolled into this study.
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 | |
Regional Cancer Program of the Sudbury Regional Hospital | |
Sudbury, Ontario, Canada, P3E 5J1 | |
Ottawa Hospital-Integrated Cancer Program | |
Ottawa, Ontario, Canada, K1H 1C4 | |
Regional Cancer Care - Thunder Bay HSC | |
Thunder Bay, Ontario, Canada, P7B 6V4 | |
The Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5G 2M9 | |
Toronto Sunnybrook Regional Cancer Centre | |
Toronto, Ontario, Canada, M4N 3M5 | |
Windsor Regional Cancer Centre | |
Windsor, Ontario, Canada, N8W 2X3 | |
Canada, Quebec | |
Montreal General Hospital | |
Montreal, Quebec, Canada, H3G 1A4 |
Study Chair: | Timothy Whelan, MD | Juravinski Cancer Centre |
Responsible Party: | Ontario Clinical Oncology Group ( Dr. Mark Levine, Director ) |
Study ID Numbers: | OCOG-2003-AROW, CBCRI-Grant-014366 |
Study First Received: | September 8, 2005 |
Last Updated: | March 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00156130 History of Changes |
Health Authority: | Canada: Health Canada |
Breast Cancer Lumpectomy Radiotherapy Hypofractionated Radiotherapy Long Term Outcomes |
Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |