giant cell tumor of bone
Conditions
Interventions
A: Surgery (Curettage+Adjuvant local therapy)
B: Preoperative denosumab+Surgery (Curettage+Adjuvant local therapy) Preoperative denosumab is administered at a dose of 120 mg on day 1, 8, 15
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosed as giant cell tumor of bone (WHO classification) using image and biopsy specimen 2) One HE staining and 10 or more unstained tumor tissue slides are available (One HE staining and 5 or more unstained tumor tissue slides are available in a case of needle biopsy) 3) No distant metastases in chest CT 4) Tumor in the extremities 5) Single tumor 6) Primary tumor (Campanacci GradeII and GradeIII) , first local recurrent tumor, or second local recurrent tumor 7) Age >= 20 and =< 70 8) An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 9) Fracture =<grade 2 (CTCAEv4.0), controllable pain by drug, and no instability in the fracture site 10) Tumor which can be treated by curettage 11) No history of denosumab 12) No history of bisphosphonate within 1 year 13) No history of osteonecrosis of the jaw 14) Sufficient organ function 15) No abnormal ECG findings 16) No possibility of pregnancy or agreement of birth control during treatments, and without breast-feeding (this applies to only women) 17) Written informed consent 18) No history of participation in this study
Exclusion criteria
Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancy except cancer with 5-year relative survival rate of 95% or more such as carcinoma in situ, intramucosal tumor, or early stage cancers. 2) Active infection requiring systemic therapy 3) Body temperature >= 38 degrees Celsius 4) Brown tumor or Paget's disease of bone 5) Psychiatric disease 6) Patients requiring systemic steroid medication or the other immunosuppressive drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Joint-preserved survival, Local relapse-free survival, Metastasis-free survival, Adverse events, Serious adverse events, Surgical and postoperative complications, Discontinuance of denosumab | — |
Countries
Japan
Contacts
Public ContactHiroshi Urakawa
JCOG1610 Coordinating Office Department of Orthopaedic Surgery, Nagoya University
Outcome results
None listed