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

NCT ID: NCT02480634

Last Updated: 2019-01-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-30
• Study Completion Date: 2022-12-31

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

Conditions

Non-small Cell Lung Cancer; Bone Metastasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Zoledronic acid

Intervention Type: DRUG

Comparison the curative effect of the high does radiotherapy and low does therapy after use the Zoledronic acid

Radiotherapy

Intervention Type: RADIATION

High dose：30Gy/10f Low dose：15Gy/5f

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

Group Type: EXPERIMENTAL

Zoledronic acid

Intervention Type: DRUG

Comparison the curative effect of the high does radiotherapy and low does therapy after use the Zoledronic acid

Radiotherapy

Intervention Type: RADIATION

High dose：30Gy/10f Low dose：15Gy/5f

Interventions

Zoledronic acid

Comparison the curative effect of the high does radiotherapy and low does therapy after use the Zoledronic acid

Intervention Type: DRUG

Radiotherapy

High dose：30Gy/10f Low dose：15Gy/5f

Intervention Type: RADIATION

Other Intervention Names

Zometa

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Wang Ge

Botanic physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ge Wang, Doctor

Role: STUDY_DIRECTOR

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

Central Contacts

Jian Li, Graduate

Role: CONTACT

lmno051049@hotmail.com

15310926602

Ge Wang, Doctor

Role: CONTACT

Wangge70@hotmail.com

13908379951

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Other Identifiers

DPRA-1023-SK

Identifier Type: -

Identifier Source: org_study_id