Multimodality approach in extra cervical locally advanced XXXX : chemoradiation, surgery and intra-operative radiation therapy. A phase II trial.

@entity1 @entity3480 @entity138 @entity5 @entity41 @entity900 @entity1349 @entity1487
BACKGROUND: The goal of this study was to determine the rational of radical surgery with intra-operative high-dose radiotherapy after chemoradiation ( @entity138 -CT) in extra cervical locally advanced @entity5 (LACC) @entity1 . METHODS: Between 2000 and 2007, 42 LACC (stage IIA bulky- @entity3480 ) @entity1 were treated at the Gynecologic Oncology Unit of the C.R.O. of Aviano in a Phase II Clinical Trial. Radiotherapy was administered to the whole pelvic region (50.4 Gy in 28 fractions) in combination with @entity900 (60 mg/mq) plus @entity1487 (750 mg/mq for 4 days) on first and fifth week of @entity138 . Radical surgery with Intra-Operative Radiation Therapy (IORT) was performed 6-8 weeks after the end of @entity138 -CT treatment. RESULTS: After @entity138 -CT, 35/42 @entity1 (83%) underwent radical surgery and IORT treatment. At pathologic examination 8/35 (23%) @entity1 showed complete response, while the rest (27/35) had residual disease either microscopic (17/27) or gross (10/27). The 5-year disease free survival (DFS) and the 5-year @entity1349 ( @entity1349 ) were 46% and 49% respectively. There were significant better DFS and @entity1349 when @entity41 was absent or limited to the cervix, respectively 78% versus 16% and 81% versus 20% (p < 0.001). All recurrences occurred within 24 months from treatment. CONCLUSIONS: @entity138 -CT followed by surgery and IORT in LACC @entity1 seems to be active in a subgroup of @entity1 with pathological complete response to treatment or partial response with @entity41 limited to the cervix.
