Zoledronic Acid Combined Radiotherapy for Bone Metastasis of Non-small Cell Lung Cancer
Primary Purpose
Non-small Cell Lung Cancer, Bone Metastasis
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Zoledronic acid
Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring zoledronic acid, radiotherapy
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
High dose group
Low dose group
Arm 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
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
Outcomes
Primary Outcome Measures
Percentage of Participants reach objective response
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
Percentage of Participants occur bone pain recurrence at 1 to 12 month after radiotherapy.
Bone pain Recurrence is defined as the time of the original parts again pain and the VAS is more than 4 points.
Pain relief time in/after treatment
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.
Incidence of SRE(Skeletal-related events) again in Participants
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
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 the osteogenic and the osteolytic sites reach objective response
Kaplan-Meier Estimates for Overall Survival after bone metastases
Full Information
NCT ID
NCT02480634
First Posted
March 17, 2015
Last Updated
January 15, 2019
Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02480634
Brief Title
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
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 2019 (Anticipated)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer, Bone Metastasis
Keywords
zoledronic acid, radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High dose group
Arm Type
Active Comparator
Arm 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
Arm Title
Low dose group
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Zoledronic acid
Other Intervention Name(s)
Zometa
Intervention Description
Comparison the curative effect of the high does radiotherapy and low does therapy after use the Zoledronic acid
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
High dose:30Gy/10f Low dose:15Gy/5f
Primary Outcome Measure Information:
Title
Percentage of Participants reach objective response
Description
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.
Time Frame
Up to 1 month
Secondary Outcome Measure Information:
Title
Percentage of Participants occur bone pain recurrence at 1 to 12 month after radiotherapy.
Description
Bone pain Recurrence is defined as the time of the original parts again pain and the VAS is more than 4 points.
Time Frame
every months up to the 12th month after treatment
Title
Pain relief time in/after treatment
Description
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.
Time Frame
everyday in treatment and every months up to 12 monthes
Title
Incidence of SRE(Skeletal-related events) again in Participants
Description
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.
Time Frame
every monthes up to the 12th month after treatment
Title
Security of the therapy
Description
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.
Time Frame
everyday in treatment and every months up to the 12th month after treatment
Title
Percentage of the osteogenic and the osteolytic sites reach objective response
Time Frame
every months up to the 12th month
Title
Kaplan-Meier Estimates for Overall Survival after bone metastases
Time Frame
every months up to the 12th month after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jian Li, Graduate
Phone
15310926602
Email
lmno051049@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ge Wang, Doctor
Phone
13908379951
Email
Wangge70@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ge Wang, Doctor
Organizational Affiliation
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Official's Role
Study Director
12. IPD Sharing Statement
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Zoledronic Acid Combined Radiotherapy for Bone Metastasis of Non-small Cell Lung Cancer
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