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Zoledronic Acid Combined Radiotherapy for Bone Metastasis of Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT02480634
Recruitment Status : Not yet recruiting
First Posted : June 24, 2015
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Wang Ge, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Tracking Information
First Submitted Date  ICMJE March 17, 2015
First Posted Date  ICMJE June 24, 2015
Last Update Posted Date January 16, 2019
Estimated Study Start Date  ICMJE June 2019
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2015)
Percentage of Participants reach objective response [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2015)
  • Percentage of Participants occur bone pain recurrence at 1 to 12 month after radiotherapy. [ Time Frame: 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.
  • Pain relief time in/after treatment [ Time Frame: 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.
  • Incidence of SRE(Skeletal-related events) again in Participants [ Time Frame: 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 [ Time Frame: 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 the osteogenic and the osteolytic sites reach objective response [ Time Frame: every months up to the 12th month ]
  • Kaplan-Meier Estimates for Overall Survival after bone metastases [ Time Frame: every months up to the 12th month after treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Zoledronic Acid Combined Radiotherapy for Bone Metastasis of Non-small Cell Lung Cancer
Official Title  ICMJE Zoledronic Acid Combined Radiotherapy for Bone Metastasis of Non-small Cell Lung Cancer: A Non-inferiority, Randomized, Open, Parallel and Controlled Prospective Clinical Study
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-small Cell Lung Cancer
  • Bone Metastasis
Intervention  ICMJE
  • Drug: Zoledronic acid
    Comparison the curative effect of the high does radiotherapy and low does therapy after use the Zoledronic acid
    Other Name: Zometa
  • Radiation: Radiotherapy
    High dose:30Gy/10f Low dose:15Gy/5f
Study Arms  ICMJE
  • Active Comparator: High dose group
    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
    Interventions:
    • Drug: Zoledronic acid
    • Radiation: Radiotherapy
  • Experimental: Low dose group
    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
    Interventions:
    • Drug: Zoledronic acid
    • Radiation: Radiotherapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 22, 2015)
280
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jian Li, Graduate 15310926602 lmno051049@hotmail.com
Contact: Ge Wang, Doctor 13908379951 Wangge70@hotmail.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02480634
Other Study ID Numbers  ICMJE DPRA-1023-SK
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wang Ge, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Study Sponsor  ICMJE Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ge Wang, Doctor Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
PRS Account Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP