Cytokine Expression During Radiation for Breast Cancer

Status: Completed
Location: See all (2) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

To assess the magnitude and frequency of changes in chemo/cytokine expression in women receiving radiation treatment. To asses the impact of race/ethnicity on the magnitude and frequency of changes in chemo/cytokine expression during radiation therapy for breast cancer. And finally to assess the interaction between radiation-induced chemo/cytokine expression changes, and race/ethnicity, with respect to normal tissue reactions to radiation and tumor-associated outcomes.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
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• Patient must be 18 years of age or older

• Patients must have histologically confirmed (by routine H\&E staining) adenocarcinoma of the breast any T, any N, M0 disease

• Patients must have undergone a segmental mastectomy (SM) with a level I and ll axillary dissection or sentinel lymph node biopsy. Surgical margins at time of local surgery must be negative greater or equal to 2mm for both invasive carcinoma and for non-invasive ductal carcinoma Patients who have post-operative margins which are negative but less than 2mm will be considered eligible if the surgeon states that the margin in question cannot be improved.

• Patients must be registered such that radiation therapy begins within 10 weeks of last surgery

• Patients must have a performance status 0 or 1 by Eastern Cooperative Oncology Group (ECOG) criteria or a 80-100 Karnofsky Performance Scale at time of consult

• Women of all races and ethnic groups are eligible for this trial

Locations
United States
Maryland
Johns Hopkins Hospital
Baltimore
The Johns Hopkins University School of Medicne
Baltimore
Time Frame
Start Date: 2009-11-13
Completion Date: 2019-11-01
Participants
Target number of participants: 82
Treatments
Other: Radiation therapy
Women with non-metastatic breast cancer status post lumpectomy to negative margins and who are receiving whole breast irradiation as per standard treatment plan.
Related Therapeutic Areas
Sponsors
Collaborators: Breast Cancer Research Foundation
Leads: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

This content was sourced from clinicaltrials.gov