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NCT02387905
Cement Augmentation in Preventing Vertebral Body Compression Fracture Following Spine Stereotactic Radiosurgery in Patients With Solid Tumors and Spinal Metastases
Phase 2 trial testing Management of Therapy Complications in Metastatic Malignant Neoplasm in the Spine in 87 participants. Participants enrolled and being followed up; not accepting new ones.
31 December 2026
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 87 |
| Start date | 9 March 2015 |
| Primary completion | 31 December 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Management of Therapy Complications
- Quality-of-Life Assessment
- Questionnaire Administration
- Stereotactic Radiosurgery
Conditions studied
- Metastatic Malignant Neoplasm in the Spine — all drugs for Metastatic Malignant Neoplasm in the Spine →
- Metastatic Malignant Solid Neoplasm — all drugs for Metastatic Malignant Solid Neoplasm →
Sponsor
M.D. Anderson Cancer Center — full company profile →
Who can join
18 and older, any sex, with Metastatic Malignant Neoplasm in the Spine or Metastatic Malignant Solid Neoplasm. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This randomized phase II trial studies how well cement augmentation works in preventing vertebral body compression fracture following spine stereotactic radiosurgery in patients with solid tumors that have spread to the spine. Spine stereotactic radiosurgery delivers a high dose of radiation to vertebral metastases and can sometimes lead to a vertebral compression fracture. Using body cement on the largest part of the vertebra (a procedure called vertebral body cement augmentation) may help prevent a fracture after stereotactic spinal radiosurgery. It may also lessen pain and improve quality of life in patients with solid tumors and spinal metastases undergoing this surgery.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Stereotactic spine radiosurgery: Review of safety and efficacy with respect to dose and fractionation.
Huo M, Sahgal A, Pryor D, Redmond K, et al · · 2017 · cited 37× · PMID 28303210 · DOI 10.4103/2152-7806.200581 -
Current and Emerging Approaches for Spine Tumor Treatment.
Costăchescu B, Niculescu AG, Iliescu BF, Dabija MG, et al · · 2022 · cited 17× · PMID 36555324 · DOI 10.3390/ijms232415680 -
Stereotactic Spinal Radiosurgery and Delayed Vertebral Fracture Risk.
Evans JD, Brown PD, Olivier KR. · · 2019 · cited 1× · PMID 30706005 · DOI 10.1016/j.adro.2018.09.005
Verify or expand the search:
- PubMed search for NCT02387905
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Management of Therapy Complications
Trials testing the same drug.
- NCT02192333 — Survivorship Care in Reducing Symptoms in Young Adult Cancer Survivors · NA · completed
- NCT01867294 — Spironolactone in Preventing Rash in Patients With Advanced Cancer Receiving Panitumumab and Cetuximab · Phase 2 · completed
Other recruiting trials for Metastatic Malignant Neoplasm in the Spine
Currently open trials in the same condition.
- NCT05178472 — Vertebroplasty With Radiation Therapy for Spine Metastatic Cancer Patients With Indeterminate Lesion (SINS Criteria) · NA · recruiting
- NCT02713269 — Thermal Ablation and Spine Stereotactic Radiosurgery in Treating Patients With Spine Metastases at Risk for Compressing · Phase 2 · active not recruiting
Other M.D. Anderson Cancer Center trials
Trials by the same sponsor.
- NCT07053020 — A Phase 1b/2 Open-label, Dose-ranging Safety and Efficacy Study of Oral Cladribine in Patients With Acute Myeloid Leukem · Phase 1, PHASE2 · not yet recruiting
- NCT07052994 — A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and · Phase 1 · not yet recruiting
- NCT07137481 — Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Che · Phase 2 · not yet recruiting
- NCT07162480 — Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Ca · Phase 2 · not yet recruiting
- NCT07076498 — Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standar · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02387905 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
- Last refreshed: 15 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02387905.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing