Genetic Susceptibility to Radiation-Induced Skin Reactions in Racial/Ethnic Groups of Patients Wi… (NCT01407770) | Clinical Trial Compass
CompletedNot Applicable
Genetic Susceptibility to Radiation-Induced Skin Reactions in Racial/Ethnic Groups of Patients With Breast Cancer
United States1,000 participantsStarted 2011-09-20
Plain-language 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 patients before and after radiation therapy may help doctors prevent toxicity and plan the best treatment.
PURPOSE: This clinical trial studies genetic susceptibility to radiation-induced skin reactions in racial/ethnic groups of patients with breast cancer.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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®…
What they're measuring
1
Occurrence of RT-induced early adverse skin reaction (EASR)