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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
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring zoledronic acid, radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    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
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    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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