This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The primary aim of this study is to compare the rate of local-regional relapse in patients receiving preoperative oral capecitabine with radiotherapy (XRT) to that in patients receiving preoperative continuous intravenous infusion (CVI) 5-FU capecitabine with radiotherapy (XRT) to that in patients receiving preoperative continuous intravenous infusion (CVI) 5-FU + XRT. The secondary aims are to: 1) downstage the primary tumor, 2) increase the number of patients undergoing sphincter-saying surgery, 3) correlate genetic patterns and the presence of absence of specific tissue biomarkers with response and prognosis, 4) compare oral capecitabine and CVI 5-FU on QOL in the setting of preoperative RT for rectal cancer, 5) examine the differences in toxicity and burden of care for the two CT treatment regimens and 6) describe the impact of the type of surgical management of rectal cancer on QOL at 1 year after surgical treatment. The tertiary aim is to establish an annotated tissue library with samples being obtained prior to therapy and following therapy, prior to surgery.
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