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

NCT02480634 | Unknown Phase 4

• 1 other identifier: DPRA-1023-SK
• Study Type: interventional
• Target: 280
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-small Cell Lung Cancer; Bone Metastasis

Keywords

zoledronic acid; radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 1 month

Secondary Outcomes (6)

• Percentage of Participants occur bone pain recurrence at 1 to 12 month after radiotherapy.

  every months up to the 12th month after treatment

• Pain relief time in/after treatment

  everyday in treatment and every months up to 12 monthes

• Incidence of SRE(Skeletal-related events) again in Participants

  every monthes up to the 12th month after treatment

• Security of the therapy

  everyday in treatment and every months up to the 12th month after treatment

• Percentage of the osteogenic and the osteolytic sites reach objective response

  every months up to the 12th month

Study Arms (2)

High dose group

ACTIVE COMPARATOR

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; Radiation: Radiotherapy

Low dose group

EXPERIMENTAL

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; Radiation: Radiotherapy

Interventions

Zoledronic acid DRUG

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

Also known as: Zometa

High dose group; Low dose group

Radiotherapy RADIATION

High dose：30Gy/10f Low dose：15Gy/5f

High dose group; Low dose group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Related Publications (31)

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MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Zoledronic Acid; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• Ge Wang, Doctor

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

  STUDY DIRECTOR

Central Study Contacts

Jian Li, Graduate

CONTACT

15310926602; lmno051049@hotmail.com

Ge Wang, Doctor

CONTACT

13908379951; Wangge70@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Botanic physician

Study Record Dates

• First Submitted: March 17, 2015
• First Posted: June 24, 2015
• Study Start: June 1, 2019
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2022
• Last Updated: January 16, 2019

Record last verified: 2019-01