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Novel Surrogate Markers as Predictors of Radiation Toxicity in Breast Cancer Patients Undergoing Helical Tomotherapy Compared to Standard Radiation Therapy


N/A
18 Years
N/A
Not Enrolling
Female
Genetic Markers, Cardiac Toxicity, Breast and Skin Motion

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Trial Information

Novel Surrogate Markers as Predictors of Radiation Toxicity in Breast Cancer Patients Undergoing Helical Tomotherapy Compared to Standard Radiation Therapy


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.


Inclusion Criteria:



- 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

Exclusion Criteria:

- collagen vascular disease

- metastatic disease

- pregnant or lactating

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

skin and cardiac toxicity

Outcome Time Frame:

24 months post RT

Safety Issue:

Yes

Principal Investigator

Bassam Abdulkarim, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Alberta Health Services

Authority:

Canada: Health Canada

Study ID:

BR-1-0090

NCT ID:

NCT00563407

Start Date:

July 2006

Completion Date:

March 2012

Related Keywords:

  • Genetic Markers
  • Cardiac Toxicity
  • Breast and Skin Motion
  • skin toxicity prediction
  • cardiac toxicity prediction
  • Breast Neoplasms
  • Radiation Injuries

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