A Phase I Study using low-dose fractionated whole abdominal radiotherapy as a chemopotentiator to full-dose XXXX for optimally debulked stage III/IV @entity189 of the endometrium.

@entity1 @entity1204 @entity137 @entity900 @entity189
OBJECTIVE: To evaluate the feasibility of combining low-dose fractionated whole abdominal radiation (LDF-WAR) with weekly full-dose @entity900 (FD-CDDP) for @entity1 with stage III/IV @entity1204 . METHODS: @entity1 with optimally debulked stage III/IV @entity189 of the endometrium (without extra-abdominal disease) were eligible for the study. Postoperatively, @entity1 received the institutional standard systemic chemotherapy and vaginal brachytherapy. @entity1 then underwent experimental six weekly cycles of FD-CDDP (40 mg/m  , maximum 70 mg IV) followed by LDF-WAR 6-8 hours after initiation of chemotherapy. In a conservative design, 6 @entity1 were accrued to two sequential cohorts of LDF-WAR, at 0.5 Gy/fraction [Fx] (total 3 Gy) and 0.75 Gy/Fx (total 4.5 Gy). @entity137 and laboratory studies were evaluated at each visit. RESULTS: Twelve @entity1 were enrolled from January 2005 to June 2009 with median follow-up of 13.5 months (range: 5-27 months). Seventy-five percent of enrolled @entity1 had uterine papillary serous histology. Eleven @entity1 at least partially completed therapy (range: 2-6 cycles of FD-CDDP/LDF-WAR) with one additional @entity1 opting out at the higher dose level. Combination therapy overall was well tolerated. Three @entity1 in each cohort experienced grade 3 acute hematologic events with one recorded grade 4 @entity137 in the second cohort. Of @entity1 receiving any of the experimental treatment, five have experienced recurrences. Three of these @entity1 were in cohort one and received 0.5 Gy/Fx LDF-WAR. CONCLUSION: Combination therapy with LDF-WAR as a novel chemopotentiator to FD-CDDP is a feasible adjuvant regimen in optimally debulked @entity1 with stage III/IV @entity1204 . Further investigation is warranted to determine treatment efficacy.
