Zoledronic Acid Combined Radiotherapy for Bone Metastasis of Non-small Cell Lung Cancer
- Conditions
- Non-small Cell Lung CancerBone Metastasis
- Interventions
- Radiation: Radiotherapy
- Registration Number
- NCT02480634
- Lead Sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 280
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High dose group Zoledronic acid 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 High dose group Radiotherapy 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 Low dose group Zoledronic acid 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 Low dose group Radiotherapy 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
- Primary Outcome Measures
Name Time Method Percentage of Participants reach objective response Up to 1 month Objective response is defined as the patients bone pain relief reach PR(Partial remission) or CR(Complete remission).and Objective response rate is defined as Objective response patients'percentage in total patients.
Time evaluation points 1 month is the time after radiotherapy.
- Secondary Outcome Measures
Name Time Method Pain relief time in/after treatment everyday in treatment and every months up to 12 monthes Pain relief time is defined as the time of the VAS(Visual analogue scale) score reduce 2 points or the analgesic reduce 25% after the radiotherapy Time evaluation points :when patients in treatment ,we shall evaluate pain scores everyday ; when patients after treatment,we shall evluate pain scores every month.
Percentage of the osteogenic and the osteolytic sites reach objective response every months up to the 12th month Kaplan-Meier Estimates for Overall Survival after bone metastases every months up to the 12th month after treatment Incidence of SRE(Skeletal-related events) again in Participants every monthes up to the 12th month after treatment Incidence of SRE again is defined as the Participants occur SRE events after treatment.
Time evaluation points :When patients were after treat,we shall evaluate whether occur SRE again every month.Security of the therapy everyday in treatment and every months up to the 12th month after treatment Time evaluation points :when patients were in treatment ,we shall evaluate the toxicity everyday ; when patients were after treatment,we shall evluate toxicity every month.
Method：Using RTOG acute radiation injury grading assessment and RTOG / EORTC late radiation injury grading for radiotherapy toxicity，CTCAE V3.0 for Adverse drug reactions.Percentage of Participants occur bone pain recurrence at 1 to 12 month after radiotherapy. every months up to the 12th month after treatment Bone pain Recurrence is defined as the time of the original parts again pain and the VAS is more than 4 points.