Exosomal as Correlative Biomarker in Clinical Outcomes in Patients Undergoing Neoadjuvant Chemoradiation Therapy for Rectal Cancer
University of Kansas Medical Center
Summary
The primary aims of this study is to characterize exosomal biomarker levels in patients with locally advanced rectal cancer undergoing neoadjuvant chemoradiation therapy. Compare rates of exosomal expression before during and after chemoradiation therapy with pathologic response rates at the time of APR or LAR. The researchers will also examine the functionality of these exosomes in malignant colonic organoids and mouse models of colorectal cancer.
Description
All male and female patients, aged 18 and older with a histologically proven diagnosis of rectal adenocarcinoma, treated on this study will receive neo adjuvant chemotherapy (consisting of 5 FU or capecitabine) given concurrently with external beam radiation therapy to a dose of 50.4 Gy in 28 fractions. Radiation treatments will be administered daily, Monday thru Friday. Within one week prior to beginning chemotherapy and radiation treatments, a serum sample will be obtained from each patient. Patients will also have serum samples collected every two weeks during radiation, and on the last day…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male and Female Patients aged 18 and older * histologically proven diagnosis of rectal adenocarcinoma * will be receiving neoadjuvant chemoradiation therapy prior to a planned definitive surgical resection Exclusion Criteria: * Age less than 18. * Patients who are unable or unwilling to undergo definitive surgery. * Patients with a prior history of pelvic external beam radiation, brachytherapy, or chemotherapy. * Patients with a prior history of cancer (excluding non-melanoma skin cancers). * Patients who are immunocompromised.
Interventions
- Diagnostic TestBlood Draw
Serum samples will be obtained from each patient enrolled
Location
- University of Kansas Medical Center/ Cancer CenterKansas City, Kansas