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

This study has been terminated.
(accrual goal met)
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00563407
First received: November 21, 2007
Last updated: September 30, 2011
Last verified: September 2011
  Purpose

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.


Condition
Genetic Markers
Cardiac Toxicity
Breast and Skin Motion

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Novel Surrogate Markers as Predictors of Radiation Toxicity in Breast Cancer Patients Undergoing Helical Tomotherapy Compared to Standard Radiation Therapy

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • skin and cardiac toxicity [ Time Frame: 24 months post RT ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • prediction [ Time Frame: 24 months post RT ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: July 2006
Estimated Study Completion Date: March 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Female patients with early breast cancer (carcinoma insitu , T1-2, N0-1) treated with lumpectomy.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00563407

Locations
Canada, Alberta
Alberta Cancer Board
Edmonton, Alberta, Canada
Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
Principal Investigator: Bassam Abdulkarim, MD AHS Cancer Control Alberta
  More Information

No publications provided

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00563407     History of Changes
Other Study ID Numbers: BR-1-0090
Study First Received: November 21, 2007
Last Updated: September 30, 2011
Health Authority: Canada: Health Canada

Keywords provided by AHS Cancer Control Alberta:
skin toxicity prediction
cardiac toxicity prediction

Additional relevant MeSH terms:
Breast Neoplasms
Radiation Injuries
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on April 17, 2014