PURPOSE: @entity1487 -based chemotherapy with concurrent radiotherapy (RT) is the standard adjuvant treatment in @entity5 . A Phase I study was conducted to determine the maximal tolerated dose and the dose-limiting @entity137 of @entity416 combined with standard RT as adjuvant treatment in @entity1 with @entity5 . METHODS AND MATERIALS: @entity1 with @entity5 after surgery were eligible. RT included a total dose of 50.4 Gy in fractions of 1.8 Gy/d, 5 d/wk, for 5.5 weeks. @entity416 was administered twice daily in escalating doses during the entire period of RT. Dose-limiting @entity137 included Grade 4 @entity1398 or @entity882 , @entity1398 , Grade 3 or greater nonhematologic @entity137 , or treatment delay because of unresolved @entity137 for >1 week. RESULTS: Thirty-one @entity1 were enrolled at the following dose levels: 1000 mg/m(2)/d (3 @entity1 ), 1150 mg/m(2)/d (4 @entity1 ) 1300 mg/m(2)/d (6 @entity1 ), 1400 mg/m(2)/d (6 @entity1 ), 1500 mg/m(2)/d (3 @entity1 ), 1600 mg/m(2)/d (3 @entity1 ), and 1700 mg/m(2)/d (6 @entity1 ). Dose-limiting @entity137 were observed in 2 @entity1 at 1300 mg/m(2)/d (Grade 3 @entity294 ), and 2 @entity1 at 1400 mg/m(2)/d ( @entity137 in 1 and @entity490 with @entity221 in 1, resulting in treatment delay), and 3 @entity1 at 1700 mg/m(2)/d (2 @entity1 had Grade 3 @entity294 and 1 had @entity8566 ). Four @entity1 presented with chronic postradiation colitis. CONCLUSIONS: The maximal tolerated dose of @entity416 given concurrently with RT was 1600 mg/m(2)/d in this study. This dose is recommended for additional use in Phase II-III studies.

Multicenter dose-finding study of concurrent @entity416 and radiotherapy as adjuvant treatment for operable XXXX .

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity', 'skin toxicity', 'toxicities'] @entity416 :: ('MESH:C110904', 'Chemical') :: ['capecitabine', 'Capecitabine'] @entity882 :: ('MESH:D013921', 'Disease') :: ['thrombocytopenia'] @entity5 :: ('MESH:D009369', 'Disease') :: ['Stage II-III rectal cancer', 'rectal cancer'] @entity294 :: ('MESH:D003967', 'Disease') :: ['diarrhea'] @entity1398 :: ('MESH:D009503', 'Disease') :: ['neutropenia', 'febrile neutropenia'] @entity8566 :: ('MESH:D060831', 'Disease') :: ['hand-foot syndrome'] @entity490 :: ('MESH:D015746', 'Disease') :: ['abdominal pain'] @entity221 :: ('MESH:D005334', 'Disease') :: ['fever'] @entity1487 :: ('MESH:D005472', 'Chemical') :: ['5-Fluorouracil']
@entity5 :: (MESH:D009369,Disease) :: ['rectal cancer']
