Genetic MarkersNCT00563407
Novel Surrogate Markers as Predictors of Radiation Toxicity in Breast Cancer Patients Undergoing Helical Tomotherapy Compared to Standard Radiation Therapy
An observational study of Genetic Markers and Cardiac Toxicity, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
Radiotherapy is standard treatment for breast cancer after lumpectomy. Although this treatment showed substantial patient benefits and decrease of local recurrence and deaths from breast cancer, it also results in some severe late side-effects, such as skin fibrosis and cardiac failure. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Genetic Markers, Cardiac Toxicity, Breast and Skin Motion
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2006to Mar 2011
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients with early breast cancer (carcinoma insitu , T1-2, N0-1) treated with lumpectomy.
Who may be able to join
- early breast cancer treated with lumpectomy
- must have T1-2 N0-1 invasive carcinoma of the breast
- must sign an informed consent
- must be at least 18 years of age
Who cannot join
- collagen vascular disease
- metastatic disease
- pregnant or lactating
Trial locations and contacts
1 site in 1 country.
About this study
Radiotherapy is standard treatment for breast cancer after lumpectomy. Although this treatment showed substantial patient benefits and decrease of local recurrence and deaths from breast cancer, it also results in some severe late side-effects, such as skin fibrosis and cardiac failure. It's possible to offer breast irradiation (RT) and minimizing toxicities radiation dose to skin, lung and heart. This will be achieved with highly conformal RT delivery using Tomotherapy. We plan to evaluate this approach in clinical study. We plan also to evaluate the value of genomic, cellular and functional imaging endpoints as predictive markers of toxicity in our breast cancer population. This program is expected to prospectively validate that Tomotherapy for breast RT can decrease skin, lung and heart toxicities and maintaining excellent cancer control after lumpectomy.
Read the detailed description
Radiotherapy is standard treatment after conservative surgery for early-stage breast cancer. Although this approach substantially improves local control and reduces deaths from breast cancer, it also results in some severe late side-effects, including skin fibrosis, deaths from radiation-induced cardiac disease and lung cancer. We will undertake a novel approach to the evaluation of radiation-induced toxicity during and after whole breast irradiation (RT) following breast-conserving surgery, with the long-term strategic goal of minimizing RT toxicity in early breast cancer. Theoretically, it is possible to achieve this goal through very highly conformal RT delivery and avoidance of RT in toxicity-prone individuals where possible. We plan to evaluate the utility of genomic analysis, cellular DNA repair competence, and functional imaging endpoints as predictive markers of toxicity in our breast cancer population. This program is expected to (a) prospectively validate that HT for breast RT can decrease acute toxicity whilst maintaining excellent cancer control after BCS; (b) demonstrate that novel surrogate markers will aid in the prediction of acute and/or late normal tissue toxicity with a view to identify toxicity-prone (or conversely, robust) individuals from amongst the breast cancer population.
- Conditions
- Genetic Markers, Cardiac Toxicity, Breast and Skin Motion
- Keywords
- skin toxicity prediction, cardiac toxicity prediction
- Medical subject headings
- Cardiotoxicity
What is being measured
The primary outcome is the main question the study is designed to answer.
skin and cardiac toxicity
Measured: 24 months post RT
Secondary outcomes (1)
prediction
Measured: 24 months post RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study startJul 2006
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: accrual goal met
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetic MarkersStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bassam Abdulkarim, MD, Principal investigator, AHS Cancer Control Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563407
- Sponsor's protocol ID
- BR-1-0090
- Status last verified
- Sep 2011
- First submitted
- 21 Nov 2007
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Surrogate Markers as Predictors of Radiation Toxicity in Breast Cancer Patients Undergoing Helical Tomotherapy Compared to Standard Radiation Therapy
- ClinicalTrials.gov ID
- NCT00563407
- Acronym / sponsor ID
- BR-1-0090
- Conditions
- Genetic Markers, Cardiac Toxicity, Breast and Skin Motion
- Keywords
- skin toxicity prediction, cardiac toxicity prediction
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: accrual goal met
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 26 Nov 2007 (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.
Radiotherapy is standard treatment for breast cancer after lumpectomy. Although this treatment showed substantial patient benefits and decrease of local recurrence and deaths from breast cancer, it also results in some severe late side-effects, such as skin fibrosis and cardiac failure. It's possible to offer breast irradiation (RT) and minimizing toxicities radiation dose to skin, lung and heart. This will be achieved with highly conformal RT delivery using Tomotherapy. We plan to evaluate this approach in clinical study. We plan also to evaluate the value of genomic, cellular and functional imaging endpoints as predictive markers of toxicity in our breast cancer population. This program is expected to prospectively validate that Tomotherapy for breast RT can decrease skin, lung and heart toxicities and maintaining excellent cancer control after lumpectomy.
Detailed description
Radiotherapy is standard treatment after conservative surgery for early-stage breast cancer. Although this approach substantially improves local control and reduces deaths from breast cancer, it also results in some severe late side-effects, including skin fibrosis, deaths from radiation-induced cardiac disease and lung cancer. We will undertake a novel approach to the evaluation of radiation-induced toxicity during and after whole breast irradiation (RT) following breast-conserving surgery, with the long-term strategic goal of minimizing RT toxicity in early breast cancer. Theoretically, it is possible to achieve this goal through very highly conformal RT delivery and avoidance of RT in toxicity-prone individuals where possible. We plan to evaluate the utility of genomic analysis, cellular DNA repair competence, and functional imaging endpoints as predictive markers of toxicity in our breast cancer population. This program is expected to (a) prospectively validate that HT for breast RT can decrease acute toxicity whilst maintaining excellent cancer control after BCS; (b) demonstrate that novel surrogate markers will aid in the prediction of acute and/or late normal tissue toxicity with a view to identify toxicity-prone (or conversely, robust) individuals from amongst the breast cancer population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients with early breast cancer (carcinoma insitu , T1-2, N0-1) treated with lumpectomy.
Key inclusion criteria (4 listed)
- early breast cancer treated with lumpectomy
- must have T1-2 N0-1 invasive carcinoma of the breast
- must sign an informed consent
- must be at least 18 years of age
Key exclusion criteria (3 listed)
- collagen vascular disease
- metastatic disease
- pregnant or lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
skin and cardiac toxicity
Time frame: 24 months post RT
1 secondary outcome
prediction
Time frame: 24 months post RT
Results and safety
The study was stopped early (reason given: accrual goal met). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 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.
Bassam Abdulkarim, MD principal investigator
AHS Cancer Control Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genetic Markers and Cardiac Toxicity, run by AHS Cancer Control Alberta at 1 site 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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: accrual goal met). Results are not available in the source record.
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.
What does the primary outcome measure?
skin and cardiac toxicity (time frame: 24 months post RT). It is what the study was designed to measure, not a finding.
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 24 Feb 2016.