Giant Cell Tumors of Bone Clinical Trial
Official title:
Phase 2 Study of the Effect of Zoledronate on Local Recurrence After Surgical Treatment of Giant Cell Tumors of Bone
The giant cell tumor (GTC) is an aggressive benign bone tumor, growing at the
metaphyseal-epiphyseal regions of long bones, especially around the knee and the distal
radius.It is responsible for bony destruction in para-articular zone fracture and leading to
the breakdown and destruction of the underlying joint.
Histologically, the tumor cell contains a contingent of monocytic cells round, a contingent
of giant type cell of type osteoclastic responsible for bone resorption that accompanies
these tumors and a contingent of lengthened cells fibroblast-like considered to be
contingent tumor.
The treatment is exclusively surgical; or by resection of the lesion which takes away tumour
and its environment, solution which, if it prevents local recurrence, imposes an important
bony and articular reconstruction, always limited and deteriorating rapidly over time in
these young patients; or by curettage of lesion, by "hollowing-out" of the bone, creating a
hole which it will be necessary to fill up by a bony grafting or a substitute of the bone
(cement). This last solution, if it preserves a better function, exposes at risk of local
recurrence,putting into play the prognosis of articulation near, most often the knee.Despite
different local adjuvants treatments used during surgical operation, after having curetted
the cavity and before filling it up, the recidivism rates vary from 12 % to 41 % (average 25
%) in literature.
The beneficial effect of the adjuvants therapeutics suggests the concept broadly accepted by
a tumoral microscopic residual at the origin of the local recidivism .Biphosphonates (BP) is
molecules which settle in vivo on the hydroxyapatite of the bone; they inhibit the
recruitment of the osteoclast forerunners and the activity of mature osteoclast. Besides,
biphosphonates containing some nitrogen (N-BP), leads to the apoptose of mature osteoclast.
These molecules also have a direct effect on tumor cells , causing apoptosis of neoplastic
cells of myeloma, of breast cancer. Clinical controlled studies confirm the experimental
data of N-BP. Two work also showed their effect on osteoclasts and stroma cells of tumours
with giant cells but no clinical study assessed potential on the prevention of the local
recurrence.
The investigators offer a study phase 2 of the effectiveness of N-BP (acid zoledronique) on
the prevention of the local recurrence of tumours with primary huge cells after surgical
treatment by curettage - filing by a surgeon referent in oncologic orthopedic surgery.
Number of patients: 24
Outcome Measures:
- Main: occurrence of recurrence detectable by Reasonable Magnetic Imaging (IRM) and / or
standardized radiography.
Local recurrence will be discussed in the presence or appearance on the radiographic and IRM
monitoring of an osteolysis in the periphery of the cavity curetted, does not exist on the
radio in post-operative with IRM signal abnormalities in the same location,taking the
gadolinium. If in doubt, a new surgical biopsy will confirm or not the diagnosis of local
recurrence
secondary:
- clinical: patient interview, clinical examination
- biological Complete blood count, creatinine, serum calcium, phosphate, magnesium
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment