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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Bone Metastasis Drug: Zoledronic acid Radiation: Radiotherapy Phase 4

Detailed Description:
Further study details as provided by oncology center of Daping hospital
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2022

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Arms and Interventions
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Arm Intervention/treatment
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
 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
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
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


  4. 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.


  5. Percentage of the osteogenic and the osteolytic sites reach objective response [ Time Frame: every months up to the 12th month ]
  6. Kaplan-Meier Estimates for Overall Survival after bone metastases [ Time Frame: every months up to the 12th month after treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02480634


Contacts
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Contact: Jian Li, Graduate 15310926602 lmno051049@hotmail.com
Contact: Ge Wang, Doctor 13908379951 Wangge70@hotmail.com

Sponsors and Collaborators
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Investigators
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Study Director: Ge Wang, Doctor Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Wang Ge, Botanic physician, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
ClinicalTrials.gov Identifier: NCT02480634    
Other Study ID Numbers: DPRA-1023-SK
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wang Ge, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University:
zoledronic acid
radiotherapy
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplastic Processes
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs