Status:
COMPLETED
Genetic Susceptibility to Radiation-Induced Skin Reactions in Racial/Ethnic Groups of Patients With Breast Cancer
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Cognitive Ability, General
Eligibility:
FEMALE
18+ years
Brief Summary
RATIONALE: Radiation therapy uses high-energy x rays to kill tumor cells. Radiation therapy may cause skin reactions when patients are exposed to high-energy x rays. Studying the genetic pattern of pa...
Detailed Description
OBJECTIVES: * To develop and validate prediction biomarkers for radiation therapy (RT)-induced acute and chronic skin reactions and quality of life in five racial/ethnic groups of breast cancer patie...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Female patients newly diagnosed with breast carcinoma including ductal carcinoma in situ (DCIS)
- Stage 0-IIIA disease
- Status post-lumpectomy, -quadrantectomy, or -mastectomy
- Plan to receive adjuvant radiation to the whole breast or chest wall and/or regional lymph nodes
- No sites that cannot send blood/urine specimens to Wake Forest by overnight (next day) express shipping
- PATIENT CHARACTERISTICS:
- \*This stratum is closed as of April 25, 2012.
- No patients who do not understand English and are unable to complete form with assistance
- PRIOR CONCURRENT THERAPY:
- Total dose \> 40 Gy, dose per fraction \> 1.8 - 2.0 Gy, use of 2D, 3D-conformal, or intensity-modulated radiation therapy (IMRT) treatment techniques allowed; a daily fraction of 2.7 Gy to the whole breast is suggested for hypofractionated regimens
- Concurrent and sequential boost techniques are allowed for both standard and hypofractionated regimens
- Adjuvant hormonal therapy will be allowed prior to, during, and/or after radiotherapy (RT) at the discretion of a medical oncologist
- Targeted therapies, such as Herceptin, will be allowed prior to, during, and/or after RT at the discretion of the medical oncologist
- No prior radiation to the involved breast or chest wall
- No concurrent chemotherapy
- No patients who underwent breast reconstruction following mastectomy
- Placement of tissue expanders and implants are not allowed
- No patients who have undergone MammoSite® or any other form of brachytherapy as well as those who will be treated with skin-sparing IMRT
- Patients may not be concurrently enrolled in a protocol that involves treatment of the skin, i.e., applying lotions/moisturizers
- Protocols that do not involve treatment of the skin are allowed
Exclusion
Key Trial Info
Start Date :
September 20 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 26 2014
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT01407770
Start Date
September 20 2011
End Date
August 26 2014
Last Update
March 28 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096