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

Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT02480634
Collaborator
(none)
280
Enrollment
2
Arms
42
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Zoledronic acid
  • Radiation: Radiotherapy
 Phase 4

Detailed Description

Further study details as provided by oncology center of Daping hospital

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Jun 1, 2019
Anticipated Primary Completion Date :
Sep 1, 2021
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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 Names:
  • 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 Names:
  • Zometa

    • Radiation: Radiotherapy
    High dose：30Gy/10f Low dose：15Gy/5f

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. Percentage of the osteogenic and the osteolytic sites reach objective response [every months up to the 12th month]

    6. Kaplan-Meier Estimates for Overall Survival after bone metastases [every months up to the 12th month after treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 109/L, Neutrophile granulocyte > 2 x 109/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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

    Investigators

    • Study Director: Ge Wang, Doctor, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    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:
    Jun 24, 2015
    Last Update Posted:
    Jan 16, 2019
    Last Verified:
    Jan 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Wang Ge, Botanic physician, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
    zoledronic acid
    radiotherapy
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Neoplasm Metastasis
    Bone Neoplasms
    Bone Marrow Diseases
    Zoledronic Acid

    Study Results

    No Results Posted as of Jan 16, 2019