Safety and Efficacy of Post-operative Denosumab Strategy for Giant Cell Tumor of Bone Treatment in China

NCT03358212 | Unknown DMC FDA Drug

• 1 other identifier: GCTB-China
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Giant Cell Tumor of Bone

Keywords

giant cell tumor of bone; Denosumab; post-operative

Outcome Measures

Primary Outcomes (1)

• recurrence without metastasis

  CT or MR proof that the tumor relapse in the primary site by at least two radiologist

  up to 2 years

Secondary Outcomes (3)

• metastasis without recurrence

  up to 2 years

• death from other disease

  up to 2 years

• death from giant cell tumor

  up to 2 years

Study Arms (1)

denosumab used postoperatively

the postoperative denosumab group, including patients receiving denosumab after piecemeal intralesional curettage aided by digital subtraction angiography(DSA) and balloon occlusion of abdominal aorta;

Drug: Denosumab

Interventions

Denosumab DRUG

Denosumab 120mg was administrated to patients by subcutaneous injection every four weeks, with loading doses on Day 8 and Day 15 of the first cycle.Patients were instructed to take calcium supplements orally every day and avoid any oral operation during treatment

Also known as: XGEVA

denosumab used postoperatively

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with giant cell tumor of bone referred to, or being treated at Peking University People's Hostpital.

You may qualify if:

• (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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Related Publications (6)

• Rutkowski 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 BACKGROUND

• Mak 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 BACKGROUND

• Ueda 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 BACKGROUND

• Branstetter 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 BACKGROUND

• Wojcik 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 BACKGROUND

• Chawla 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.

  PMID: 23867211 BACKGROUND

MeSH Terms

Conditions

Giant Cell Tumor of Bone

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Giant Cell Tumors; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Bone Tissue

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Guo Wei

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen Zhongyan, MD

CONTACT

+8615201285835; harrypotterchen@126.com

Yang Yi, MD,PHD

CONTACT

+86-13701312827; bonetumor@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Musculoskeltal Tumor Center

Study Record Dates

• First Submitted: November 26, 2017
• First Posted: November 30, 2017
• Study Start: March 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: June 1, 2021
• Last Updated: November 30, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share