Clinical trial NCT02480634: Zoledronic Acid Combined Radiotherapy for Bone Metastasis of Non-small Cell Lung Cancer
Official title: Zoledronic Acid Combined Radiotherapy for Bone Metastasis of Non-small Cell Lung Cancer: A Non-inferiority, Randomized, Open, Parallel and Controlled Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Non-small Cell Lung Cancer
Bone Metastasis
Keywords: zoledronic acid
radiotherapy
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
First posted: 2015-06-24
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Further study details as provided by oncology center of Daping hospital

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants reach objective response
timeFrame: Up to 1 month
Secondary outcomes:
measure: Percentage of Participants occur bone pain recurrence at 1 to 12 month after radiotherapy.
timeFrame: every months up to the 12th month after treatment
measure: Pain relief time in/after treatment
timeFrame: everyday in treatment and every months up to 12 monthes
measure: Incidence of SRE(Skeletal-related events) again in Participants
timeFrame: every monthes up to the 12th month after treatment
measure: Security of the therapy
timeFrame: everyday in treatment and every months up to the 12th month after treatment
measure: Percentage of the osteogenic and the osteolytic sites reach objective response
timeFrame: every months up to the 12th month
measure: Kaplan-Meier Estimates for Overall Survival after bone metastases
timeFrame: every months up to the 12th month after treatment
Other outcomes:
Locations:
Study officials:
affiliation: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
name: Ge Wang, Doctor
role: STUDY_DIRECTOR
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