Phase I/II study of XXXX and @entity901 chemotherapy in combination with concurrent 3-D conformal radiotherapy for locally advanced @entity1149 .

@entity901 @entity1 @entity137 @entity2910 @entity1149 @entity358 @entity136
BACKGROUND: Recent studies have showed that combination of chemotherapy and radiotherapy might result in better outcome for locally advanced @entity1149 ( @entity1149 ). The aim of this study is to determine the maximal tolerance dose (MTD) and efficacy of full-dose @entity136 and @entity901 when given concurrently with 3-dimentional radiation therapy (3D-RT) for locally advanced @entity1149 . METHODS: @entity901 was administered at a fixed dose of 130mg/m  , and @entity136 was administered at a starting dose of 800mg/m   with an incremental dose gradient of 200mg/m   for 3 dose levels. MTD was defined as the immediate dose level lower than the dose at which dose-limiting @entity137 (DLT) occurred in more than one-third of the @entity1 . The chemotherapy was administered at 3-week cycle. The RT was given as 3-D conformal manner at a single daily dose of 2Gy for 5 days per week. RESULTS: Twenty-two @entity1 were evaluable and distributed to three different dose levels: 6 at level 1, 8 at level 2 and 8 at level 3. @entity358 , esophageal and hematologic @entity137 were the main DLT. Grade III acute @entity358 occurred in one @entity1 each at level 2 and level 3, both with V20 > 20%, and grade III @entity2910 in two @entity1 at level 3. The MTD of @entity136 in this study was 1000mg/m  . The overall response rate was 75.0% (9/12). The 1- and 2-year survival rate was 70.0% and 30.5% respectively. The median time to progression was 8.7 months (range 5-11.8 months). CONCLUSIONS: With reduced radiation volume, @entity136 of 1000mg/m   in combination with @entity901 of 130mg/m   was effective and could be safely administered for @entity1149 .
