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

January 15, 2019 updated by: Wang Ge, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Zoledronic Acid Combined Radiotherapy for Bone Metastasis of Non-small Cell Lung Cancer: A Non-inferiority, Randomized, Open, Parallel and Controlled Prospective Clinical Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Further study details as provided by oncology center of Daping hospital

Study Type

Interventional

Enrollment (Anticipated)

280

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
every months up to the 12th month after treatment
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.
everyday in treatment and every months up to 12 monthes
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.
every monthes up to the 12th month after treatment
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.
everyday in treatment and every months up to the 12th month after treatment
Percentage of the osteogenic and the osteolytic sites reach objective response
Time Frame: every months up to the 12th month
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
every months up to the 12th month after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 1, 2019

Primary Completion (ANTICIPATED)

September 1, 2021

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

March 17, 2015

First Submitted That Met QC Criteria

June 22, 2015

First Posted (ESTIMATE)

June 24, 2015

Study Record Updates

Last Update Posted (ACTUAL)

January 16, 2019

Last Update Submitted That Met QC Criteria

January 15, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DPRA-1023-SK

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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