NCT05595603RecruitingPhase 2
Zoledronic Acid-loaded Bone Cement as a Local Adjuvant Therapy for Giant Cell Bone Tumor After Intralesional Curettage
Zoledronic Acid-loaded Bone Cement as a Local Adjuvant Therapy for Giant Cell Bone Tumor After Intralesional Curettage: a Prospective, Multicenter, Single Blinded, Randomized Control Trial.
Source: ClinicalTrials.gov · Last updated 15 Mar 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The purpose of this study is to investigate whether zoledronic acid-loaded bone cement (4mg ZOL+ gentamicin PMMA ) as adjuvant method can decrease local recurrence in patients with giant cell bone tumor following intralesional curettage surgery. The hypothesis is that patients with local administration of zoledronic acid to the bone cement has lower relapse rate compared those with traditional bone cement(gentamicin PMMA ).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 153 (estimated)
- First submitted
- 23 Oct 2022
- Start date
- Mar 2023
- Primary completion date
- 1 Jun 2026
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- Childhood cancers
- NCT number
- NCT05595603
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 153
- From Mar 2023 to the primary completion date, 1 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- patients with recurrent GCT or extensive GCT which is impossible or inappropriate to use curettage surgery due to its "unresectable" nature.
- conduct unexpected surgery at other center
- the primary goal for surgery is revision
- patient conduct en-bloc/wide resection instead of curettage surgery
- previous use of bisphosphonate/ZOL or denosumab drug
Other
- patient can not conduct self-assessment during follow up
- difficulty in complete postoperative follow-up
- patients have participated in similar research projects
- refused to sign informed consent
Who the study is looking for
- patients with primary resectable GCT of bone
- lesion amenable to reconstruction (intralesional curettage) defined as having at least one intact column of bone after removal
- no previous systemic bisphosphonate or denosumab therapy
- with expected longer than 18 months of survival time
- sign the informed consent form
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Affiliated Hospital of Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.