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

NCT00563407 | Terminated DMC

• 1 other identifier: BR-1-0090
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Genetic Markers; Cardiac Toxicity; Breast and Skin Motion

Keywords

skin toxicity prediction; cardiac toxicity prediction

Outcome Measures

Primary Outcomes (1)

• skin and cardiac toxicity

  24 months post RT

Secondary Outcomes (1)

• prediction

  24 months post RT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• collagen vascular disease
• metastatic disease
• pregnant or lactating

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead

Study Sites (1)

Alberta Cancer Board

Edmonton, Alberta, Canada

Location

MeSH Terms

Conditions

Cardiotoxicity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Officials

• Bassam Abdulkarim, MD

  AHS Cancer Control Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2007
• First Posted: November 26, 2007
• Study Start: July 1, 2006
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: February 24, 2016

Record last verified: 2011-09

Locations

CA (1)