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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

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

NCT ID

NCT02480634

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

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

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 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

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

lmno051049@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ge Wang, Doctor

Phone

13908379951

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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