Breast CancerNCT00156130
Accelerated Radiotherapy Outcomes in Women
An observational study of Breast Cancer, run by Ontario Clinical Oncology Group (OCOG) at 11 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Conventional radiotherapy schedule and Accelarated radiotherapy schedule
- Type of treatment
- Surgery or procedure
- How many people
- 1,234 participants
- Where
- 11 sitesCanada
- Study dates
- Oct 2003to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Canada11 sites
Regional Cancer Program of the Sudbury Regional Hospital
Greater Sudbury, Ontario, P3E 5J1
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, K7L 5P9
London Regional Cancer Centre
London, Ontario, N6A 4L6
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Ottawa Hospital-Integrated Cancer Program
Ottawa, Ontario, K1H 1C4
Niagara Health System
St. Catharines, Ontario, L2R 5K3
Regional Cancer Care - Thunder Bay HSC
Thunder Bay, Ontario, P7B 6V4
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
The Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3
About this study
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)
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Conventional radiotherapy schedule, Accelarated radiotherapy schedule
- Keywords
- Breast Cancer, Lumpectomy, Radiotherapy, Hypofractionated Radiotherapy, Long Term Outcomes
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional radiotherapy scheduleRadiation
50 Gy in 25 fractions over 35 days
Accelarated radiotherapy scheduleRadiation
42.5 Gy in 16 fractions over 22 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Accelerated whole breast irradiation Receives: Radiation: Accelarated radiotherapy schedule | |
| 2 | Conventional whole breast irradiation Receives: Radiation: Conventional radiotherapy schedule |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startOct 2003
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Breast Cancer Research Alliance
- Responsible party
- Sponsor
- Investigators
- Timothy Whelan, MD, Study chair, Juravinski Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00156130
- Sponsor's protocol ID
- OCOG-2003-AROW
- Other IDs
- CBCRI-Grant-014366
- Status last verified
- Jun 2015
- First submitted
- 8 Sep 2005
- Last updated
- 9 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00156130
- Acronym / sponsor ID
- OCOG-2003-AROW
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Lumpectomy, Radiotherapy, Hypofractionated Radiotherapy, Long Term Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,234 participants (actual)
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)University, hospital or other
- Collaborators
- Canadian Breast Cancer Research Alliance
- Study start
- Oct 2003
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Radiation: Accelarated radiotherapy scheduleAccelerated whole breast irradiation |
| 2 | – | Radiation: Conventional radiotherapy scheduleConventional whole breast irradiation |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional radiotherapy schedule50 Gy in 25 fractions over 35 days | Radiation | 2 |
| Accelarated radiotherapy schedule42.5 Gy in 16 fractions over 22 days | Radiation | 1 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Whelan, MD study chair
Juravinski Cancer Centre
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Ontario Clinical Oncology Group (OCOG) at 11 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2016.