Clinical trial · Observational
Safety and Efficacy of Post-operative Denosumab Strategy for Giant Cell Tumor of Bone Treatment in China
Safety and Efficacy of Post-operative Denosumab Strategy for Giant Cell Tumor of Bone Treatment in China：Correlation Between Recurrence and Drug Withdrawl
NCT03358212CI-TRIAL-00030615unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This prospective observational study is going to figure out the safety and efficacy of denosumab as an post-operative strategy.All the patients enrolled will take denosumab according to the protocols.We focus on the recurrence rate after the drug withdrawl and possibility of malignant transformation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Giant Cell Tumor of Bone | Giant Cell Tumor of Bone | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Denosumab | Drug | Denosumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- denosumab used postoperatively
- description
- the postoperative denosumab group, including patients receiving denosumab after piecemeal intralesional curettage aided by digital subtraction angiography(DSA) and balloon occlusion of abdominal aorta;
- interventionNames
- Drug: Denosumab
Primary outcomes (1)
- measure
- recurrence without metastasis
- timeFrame
- up to 2 years
- description
- CT or MR proof that the tumor relapse in the primary site by at least two radiologist
Secondary outcomes (3)
- measure
- metastasis without recurrence
- timeFrame
- up to 2 years
- description
- confirmed via lung CT scan by at least two radiologist
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: (1) With treatment-naïve sacral GCT firstly treated in our center (for referral patients, only those with definite diagnosis were included); (2)single center lesion (3) Being diagnosed with classic GCTB by puncture pathology prior to treatment (for referral patients, definite diagnosis shall be made by the Pathology Department in our center through pathology consultation on tissue sections); (4) previously denosumab-naïve. Exclusion Criteria:(1)primary malignant giant cell tumor of bone(2)radiation therapy in history(3)lung metastasis at first diagnosis
References
Publications (6)
- BACKGROUNDRutkowski P, Ferrari S, Grimer RJ, Stalley PD, Dijkstra SP, Pienkowski A, Vaz G, Wunder JS, Seeger LL, Feng A, Roberts ZJ, Bach BA. Surgical downstaging in an open-label phase II trial of denosumab in patients with giant cell tumor of bone. Ann Surg Oncol. 2015 Sep;22(9):2860-8. doi: 10.1245/s10434-015-4634-9. Epub 2015 Jun 2. PMID 26033180
- BACKGROUNDMak IW, Evaniew N, Popovic S, Tozer R, Ghert M. A Translational Study of the Neoplastic Cells of Giant Cell Tumor of Bone Following Neoadjuvant Denosumab. J Bone Joint Surg Am. 2014 Aug 6;96(15):e127. doi: 10.2106/JBJS.M.01332. PMID 25100780
- BACKGROUNDUeda T, Morioka H, Nishida Y, Kakunaga S, Tsuchiya H, Matsumoto Y, Asami Y, Inoue T, Yoneda T. Objective tumor response to denosumab in patients with giant cell tumor of bone: a multicenter phase II trial. Ann Oncol. 2015 Oct;26(10):2149-54. doi: 10.1093/annonc/mdv307. Epub 2015 Jul 23. PMID 26205395
- BACKGROUNDBranstetter DG, Nelson SD, Manivel JC, Blay JY, Chawla S, Thomas DM, Jun S, Jacobs I. Denosumab induces tumor reduction and bone formation in patients with giant-cell tumor of bone. Clin Cancer Res. 2012 Aug 15;18(16):4415-24. doi: 10.1158/1078-0432.CCR-12-0578. Epub 2012 Jun 18. PMID 22711702
- BACKGROUNDWojcik J, Rosenberg AE, Bredella MA, Choy E, Hornicek FJ, Nielsen GP, Deshpande V. Denosumab-treated Giant Cell Tumor of Bone Exhibits Morphologic Overlap With Malignant Giant Cell Tumor of Bone. Am J Surg Pathol. 2016 Jan;40(1):72-80. doi: 10.1097/PAS.0000000000000506. PMID 26414220
- BACKGROUNDChawla S, Henshaw R, Seeger L, Choy E, Blay JY, Ferrari S, Kroep J, Grimer R, Reichardt P, Rutkowski P, Schuetze S, Skubitz K, Staddon A, Thomas D, Qian Y, Jacobs I. Safety and efficacy of denosumab for adults and skeletally mature adolescents with giant cell tumour of bone: interim analysis of an open-label, parallel-group, phase 2 study. Lancet Oncol. 2013 Aug;14(9):901-8. doi: 10.1016/S1470-2045(13)70277-8. Epub 2013 Jul 16.