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

Army Medical University of People's Liberation Army

Status and phase: Unknown; Phase 4

Conditions: Non-small Cell Lung Cancer; Bone Metastasis

Treatments: Radiation: Radiotherapy; Drug: Zoledronic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02480634

DPRA-1023-SK

Details and patient eligibility

About

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.

Full description

Further study details as provided by oncology center of Daping hospital

Enrollment: 280 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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280 participants in 2 patient groups

High dose group

Active Comparator group

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

Treatment:

Drug: Zoledronic acid

Radiation: Radiotherapy

Low dose group

Experimental group

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

Treatment:

Drug: Zoledronic acid

Radiation: Radiotherapy