PURPOSE: The use of oral chemotherapeutic agents in chemoradiotherapy provides several advantages. @entity1013 , an oral @entity1487 prodrug, has been shown to be effective in @entity14 . We attempted a Phase II trial of preoperative chemoradiotherapy with @entity1013 plus a low-dose oral @entity4181 in unresectable primary @entity5 @entity1 . In this study, @entity137 and efficacy were evaluated. METHODS AND MATERIALS: There were 23 @entity1 with primary unresectable @entity5 in this trial, 21 of whom were available for analysis. The @entity1 were treated with oral @entity1013 (900 mg/day) plus oral @entity4181 (30 mg/day) from days 1 to 35, and pelvic radiation of 45 Gy over 5 weeks. Surgical resection was performed 5-6 weeks after the treatment. RESULTS: Acute @entity137 involved @entity882 , @entity390 / @entity391 , @entity294 , and skin reaction. All were in Grade 1/2, except @entity294 , which was not only the most frequent (7 @entity1 , 33.3%), but also the only @entity137 of Grade 3 (2 @entity1 ). The clinical @entity5 response was shown in 5 @entity1 (23.8%) as a complete response and 13 @entity1 (61.9%) as a partial response. A complete resection with negative resection margin was done in 18 @entity1 (85.7%), in 2 of whom a pathologic complete response was shown (9.5%). The overall downstaging rate in the T- and N-stage groupings was 71.4% (15 @entity1 ). CONCLUSION: This study demonstrated the efficacy and low @entity137 of chemoradiotherapy with @entity1013 . Currently, a Phase III randomized trial of chemoradiotherapy is ongoing at our institute to compare the therapeutic efficacy of oral @entity1487 with respect to i.v. @entity1487 in locally advanced and unresectable @entity5 .

Preoperative chemoradiotherapy with oral @entity1013 plus low-dose oral @entity4181 in unresectable primary XXXX .

@entity4181 :: ('MESH:D002955', 'Chemical') :: ['leucovorin'] @entity1 :: ('9606', 'Species') :: ['patients'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity'] @entity390 :: ('MESH:D009325', 'Disease') :: ['nausea'] @entity882 :: ('MESH:D013921', 'Disease') :: ['thrombocytopenia'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumor', 'rectal cancer'] @entity294 :: ('MESH:D003967', 'Disease') :: ['diarrhea'] @entity391 :: ('MESH:D014839', 'Disease') :: ['vomiting'] @entity14 :: ('MESH:D015179', 'Disease') :: ['colorectal cancer'] @entity1013 :: ('MESH:C025034', 'Chemical') :: ['doxifluridine', 'Doxifluridine'] @entity1487 :: ('MESH:D005472', 'Chemical') :: ['5-FU']
@entity5 :: (MESH:D009369,Disease) :: ['rectal cancer']
