Randomized Phase II Study of Zoledronic Acid vs Observation on Bone Mineral Density and Incidence of Micrometastasis in Women Undergoing Pelvic Radiation for Cervical Cancer
- To determine the incidence of disseminated tumor cells (DTCs) in bone marrow and
circulating tumor cells (CTCs) in the blood of women with cervical cancer at diagnosis
and 3 to 9 months after chemotherapy and pelvic radiation with and without Zometa.
- To determine the change in biochemical markers of bone turnover from diagnosis to 9
months after radiation in women receiving chemoradiation for cervical cancer with and
- To determine change in bone mineral density from diagnosis to 9 month after
chemoradiation with and without Zometa.
- To determine if depressed and anxious mood are associated with greater impairment of
adaptive immunity (ratio of Th1/Th2) and higher levels of angiogenesis (VEGF) in
peripheral blood of cervical cancer patients.
- To examine the relationship of SUVMax and metabolic heterogeneity in the primary tumor
and evidence of persistent/recurrent disease on the 3 and 9 month FDG-PET scans with
DTCs and CTCs.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
FDG-PET Metabolic Response
Assessed qualitatively, at 3 and 9 months.
Perry Grigsby, M.D., M.S., M.B.A
Washington University School of Medicine
United States: Food and Drug Administration