Clinical trial · Interventional
Zoledronic Acid Combined Radiotherapy for Bone Metastasis of Non-small Cell Lung Cancer
Zoledronic Acid Combined Radiotherapy for Bone Metastasis of Non-small Cell Lung Cancer: A Non-inferiority, Randomized, Open, Parallel and Controlled Prospective Clinical Study
- 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 study will give comparison of the bone pain remission and the adverse reaction of Zoledronic acid combine with High dose fractionation radiotherapy(30Gy/10f) and Zoledronic acid combine with low dose fractionation radiotherapy(15Gy/5f) . The purpose of this trial is to prove whether Zoledronic acid combine radiotherapy can reduce radiotherapy dose in treatment of non-small cell lung cancer bone metastasis'pain relief or not.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Metastasis | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Radiation | — | UNRESOLVED |
| Zoledronic acid | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- High dose group
- description
- Zoledronic acid 4 mg + 0.9% sodium chloride injection 100 ml intravenous drip more than 15 min, 28 days for a transfusion cycle , a total of six cycle,Radiotherapy dose: 30Gy/10f
- interventionNames
- Drug: Zoledronic acid
- Radiation: Radiotherapy
- type
- EXPERIMENTAL
- label
- Low dose group
- description
- Zoledronic acid 4 mg + 0.9% sodium chloride injection 100 ml intravenous drip more than 15 min, 28 days for a transfusion cycle, a total of six cycle,Radiotherapy dose: 15Gy/5f
- interventionNames
- Drug: Zoledronic acid
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathology or cytology was diagnosed with non-small cell lung cancer, and bone metastases was confirmed by CT or MRI , and the patients have to need intervention treatment. * VAS score\>2 points. * No paraplegia, * No pathological fractures of bone related events which require surgical intervention, * No major organ dysfunction,laboratory indexes meet the following requirements: Haemamoeba \>4.0 x 10\^9/L, Neutrophile granulocyte \> 2 x 10\^9/L, the platelet count\>100 x 10\^9/L, hemoglobin\>100 g/L; Liver result: the serum bilirubin is lower than normal ceiling; ALT and AST is lower than the maximum normal 1.5 times; Cr\<265 umol/l or 3.0 mg/dl, creatinine clearance\>60 ml/min. Exclusion Criteria: * The patients who have allergy of Bisphosphonates and zoledronate. * The patients who receive Molecular targeted therapy and chemotherapy within one month,The patients who receive Calcitonin and Aminoglycoside therapy in one week. * The patients who receive Pamidronic Acid in 28 days,The patients original sites receive radiotherapy before. * The patients who have history of thyroid surgery,receive tooth extraction in 2 weeks,and have been suffered from Bone Fracture and paraplegia. * The patients who have Serious internal medicine diseases and acute infection. * The patients With a history of psychiatric * Pregnancy or breast-feeding women, men have fertility requirements * Patients within clinical trials or not more than 30 days
References
Publications (31)
- BACKGROUNDAkbar RA, Gosh SK, Khalil S, ul Haq SM. Zoledronic acid in metastatic bone disease: an audit based discussion. J Ayub Med Coll Abbottabad. 2010 Jul-Sep;22(3):5-7. PMID 22338405
- BACKGROUNDWu JS, Wong R, Johnston M, Bezjak A, Whelan T; Cancer Care Ontario Practice Guidelines Initiative Supportive Care Group. Meta-analysis of dose-fractionation radiotherapy trials for the palliation of painful bone metastases. Int J Radiat Oncol Biol Phys. 2003 Mar 1;55(3):594-605. doi: 10.1016/s0360-3016(02)04147-0. PMID 12573746
- BACKGROUNDChow E, Wu JS, Hoskin P, Coia LR, Bentzen SM, Blitzer PH. International consensus on palliative radiotherapy endpoints for future clinical trials in bone metastases. Radiother Oncol. 2002 Sep;64(3):275-80. doi: 10.1016/s0167-8140(02)00170-6. PMID 12242115
- BACKGROUNDChow E, Hoskin P, Mitera G, Zeng L, Lutz S, Roos D, Hahn C, van der Linden Y, Hartsell W, Kumar E; International Bone Metastases Consensus Working Party. Update of the international consensus on palliative radiotherapy endpoints for future clinical trials in bone metastases. Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):1730-7. doi: 10.1016/j.ijrobp.2011.02.008. Epub 2011 Apr 12. PMID 21489705
- BACKGROUNDDennis K, Makhani L, Zeng L, Lam H, Chow E. Single fraction conventional external beam radiation therapy for bone metastases: a systematic review of randomised controlled trials. Radiother Oncol. 2013 Jan;106(1):5-14. doi: 10.1016/j.radonc.2012.12.009. Epub 2013 Jan 13. PMID 23321492
- BACKGROUNDLuo KW, Ko CH, Yue GG, Lee MY, Siu WS, Lee JK, Shum WT, Fung KP, Leung PC, Li G, Evdokiou A, Lau CB. Anti-tumor and anti-osteolysis effects of the metronomic use of zoledronic acid in primary and metastatic breast cancer mouse models. Cancer Lett. 2013 Oct 1;339(1):42-8. doi: 10.1016/j.canlet.2013.07.024. Epub 2013 Jul 26. PMID 23896464