This pilot study focuses on KD018, a standardized and well-characterized Chinese herbal medicine, and will investigate the effect of this agent on reducing the GI toxicity associated with combined modality therapy of locally-advanced rectal cancer. In this study, KD018 will be administered concomitantly with Capecitabine and pelvic radiation therapy (RT) in the neoadjuvant setting, with the hypothesis that KD018 will reduce the gastrointestinal side effects, namely diarrhea, secondary to treatment with Capecitabine plus external beam radiation therapy (EBRT).~The primary endpoint of the study is to investigate the grade 3-4 toxicity rate associated with a course of chemo-radiation with concomitant Capecitabine and KD018, and to compare this to the toxicity seen in patients treated with Capecitabine and radiation therapy alone, in patients with T3-T4 and N0-N2, M0 rectal cancer. Secondary objectives include the assessment of radiographic response to therapy (using pelvic MRI) and assessment of the pathologic CR rate by examination of the pathologic specimen. In addition, we will perform an analysis of plasma levels of pro-inflammatory cytokines and chemokines.~This trial is designed to accrue approximately 24 patients over the course of 24 months.
This pilot study focuses on KD018 and will investigate the effect of this agent on reducing the Gastrointestinal (GI) toxicity associated with combined modality therapy of locally-advanced rectal cancer.