- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00156130
Accelerated Radiotherapy Outcomes in Women
May 6, 2016 updated by: Ontario Clinical Oncology Group (OCOG)
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
1234
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8V 5C2
- Juravinski Cancer Centre
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Kingston, Ontario, Canada, K7L 5P9
- Cancer Centre of Southeastern Ontario At Kingston General Hospital
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London, Ontario, Canada, N6A 4L6
- London Regional Cancer Centre
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Ottawa, Ontario, Canada, K1H 1C4
- Ottawa Hospital-Integrated Cancer Program
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St. Catharines, Ontario, Canada, L2R 5K3
- Niagara Health System
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Sudbury, Ontario, Canada, P3E 5J1
- Regional Cancer Program of the Sudbury Regional Hospital
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Thunder Bay, Ontario, Canada, P7B 6V4
- Regional Cancer Care - Thunder Bay HSC
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Toronto, Ontario, Canada, M4N 3M5
- Toronto Sunnybrook Regional Cancer Centre
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Toronto, Ontario, Canada, M5G 2M9
- The Princess Margaret Hospital
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Windsor, Ontario, Canada, N8W 2X3
- Windsor Regional Cancer Centre
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Quebec
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Montreal, Quebec, Canada, H3G 1A4
- Montreal General Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
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.
Description
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:
- The female patient has a histological diagnosis of invasive carcinoma of the breast, and no evidence of metastatic disease.
- Has had a lumpectomy (including segmental resection and partial mastectomy), that is, surgical excision of the tumour with a rim of normal tissue.
- Patient has not had an axillary dissection, OR for patients who have had an axillary dissection, all nodes are negative for metastatic disease.
Exclusion Criteria:
- Tumour greater than 5 cm in greatest diameter on pathological examination.
- The presence of invasive or intraductal (noninvasive) breast cancer involving the surgical margins.
- Clinical evidence prior to surgery of infiltration of the skin of the involved breast such as edema, ulceration, or fixation of the tumour to underlying muscle, or inflammatory breast cancer.
- Bilateral malignancy of the breast (synchronous or metachronous).
- More than one primary invasive tumour in the same breast.
- Previous surgery for breast cancer.
- Pathological status of axilla is unknown.
- Status for adjuvant systemic therapy not determined.
- For patients not treated with adjuvant chemotherapy: unable to commence radiation therapy within 16 weeks of last surgical procedure on the breast.
- For patients treated with adjuvant chemotherapy: unable to commence radiation therapy within 8 weeks of the last dose of chemotherapy.
- Serious nonmalignant disease (eg. cardiovascular, renal, etc.) which would preclude surgical or radiation treatment.
- Currently pregnant or lactating.
- Breast deemed too large to permit satisfactory radiation (ie. separation > 25 cm).
- Previous concomitant malignancies of any type except squamous, or basal cell carcinomas of the skin, or carcinoma in situ of the cervix which have been effectively treated.
- Geographic inaccessibility for follow-up.
- Psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
Accelerated whole breast irradiation
|
42.5 Gy in 16 fractions over 22 days
|
2
Conventional whole breast irradiation
|
50 Gy in 25 fractions over 35 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2003
Primary Completion (ACTUAL)
June 1, 2015
Study Completion (ACTUAL)
June 1, 2015
Study Registration Dates
First Submitted
September 8, 2005
First Submitted That Met QC Criteria
September 9, 2005
First Posted (ESTIMATE)
September 12, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
May 9, 2016
Last Update Submitted That Met QC Criteria
May 6, 2016
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OCOG-2003-AROW
- CBCRI-Grant-014366
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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