Clinical Trials (PDQ®)
|No phase specified||Biomarker/Laboratory analysis, Natural history/Epidemiology, Treatment||Completed||18 and over||NCI||CCCWFU97609|
U10CA081851, WFU-97609, NCT01407770
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.
Further Study Information
- 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 patients, Whites*, Black/African Americans, Hispanic/Latinos, Asians/Native Hawaiians/Pacific Islanders, and American Indians/Alaskan Natives. NOTE: *This stratum is closed as of April 25, 2012.
- To develop polygenic models of RT-induced skin reactions with a comprehensive evaluation of genome-wide nonsynonymous single nucleotide polymorphisms (nsSNPs).
- To evaluate the levels of DNA damage (Comet assay) and radiosensitivity (Cell Cycle G2 Delay assay) in lymphocytes before and after RT.
- To test the effect of gene-gene and gene-smoking interactions on RT-induced skin reactions.
- To assess race-ethnic differences in RT-induced skin reactions, DNA damage, and radiosensitivity and to determine if the gene effects are consistent across race-ethnicity (gene-race/ethnic interactions).
OUTLINE: This is a multicenter study. Patients are stratified according to race/ethnicity (Whites* vs Black/African Americans vs Hispanic/Latinos vs Asians/Native Hawaiians/Pacific Islanders vs American Indians/Alaskan Natives). NOTE: *This stratum is closed as of April 25, 2012.
Patients undergo adjuvant radiotherapy after breast-conserving surgery.
Blood and urine samples are collected at baseline and last day of radiotherapy for genotyping, DNA damage, cell cycle assays, urine cotinine, inflammatory immune response biomarkers, and tumor-killing activity by BeadArray System, Comet assay, flow cytometry-based assay, Cell-Cycle G2 Delay Assay, Oxygen Radical Absorbance Capacity (ORAC) assay, and ELISA.
Patients are assessed for acute toxicity by research staff using the ONS Criteria for Radiation-Induced Acute Skin Toxicity at baseline, week 3, and at 1 and 2 months after radiotherapy. Patients are also assessed for chronic toxicity by research staff using the Chronic skin toxicity questionnaire (RTOG SOMA Criteria for RT- Induced Breast/Chest Wall Late Skin Toxicity) at 6 and 12 months after completion of radiotherapy. Photographs of the breast, chest wall, and contralateral breast are also taken at baseline, week 3, last day of radiotherapy, and at 1, 2, 6, and 12 months after completion of radiotherapy.
Patients complete the Breast Cancer Risk Study Questionnaire, the Functional Assessment of Cancer Therapy Breast (FACT-B), the Modified Skindex, and the B39 Quality-of-Life (QOL) Questionnaire at baseline, last day of radiotherapy, and at 1, 2, 6, and 12 months after radiotherapy.
- 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
- *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
Trial Lead Organizations/Sponsors
Wake Forest NCORP Research BaseNational Cancer Institute
|James J. Urbanic||Principal Investigator|
|La Grange Memorial Hospital|
|Jeffrey M Feinstein||Ph: 630-654-1790|
|St. Francis Hospital and Health Centers - Beech Grove Campus|
|Howard M. Gross||Ph: 765-983-3000|
|Central Maine Comprehensive Cancer Center at Central Maine Medical Center|
|Courtney A Jensen||Ph: 207-795-8250|
|Frank and Edith Scarpa Regional Cancer Pavillion at South Jersey Healthcare|
|Glenda R. Smith||Ph: 856-641-7933|
|All Saints Cancer Center at Wheaton Franciscan Healthcare|
|James H. Taylor||Ph: 414-874-4541|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01407770
ClinicalTrials.gov processed this data on January 12, 2015
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