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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02480634
• Other study ID #: DPRA-1023-SK
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 2019
• Est. completion date: December 2022

Study information

• Verified date: January 2019
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: Jian Li, Graduate
• Phone: 15310926602
• Email: lmno051049[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Further study details as provided by oncology center of Daping hospital

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 280
• Est. completion date: December 2022
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Metastasis
• Bone Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Neoplasm Metastasis
• Non-small Cell Lung Cancer

Intervention

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

Radiation:
• Radiotherapy
High dose:30Gy/10f Low dose:15Gy/5f

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

References & Publications (31)

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* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	every months up to the 12th month after treatment
Secondary	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.	everyday in treatment and every months up to 12 monthes
Secondary	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.	every monthes up to the 12th month after treatment
Secondary	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.	everyday in treatment and every months up to the 12th month after treatment
Secondary	Percentage of the osteogenic and the osteolytic sites reach objective response		every months up to the 12th month
Secondary	Kaplan-Meier Estimates for Overall Survival after bone metastases		every months up to the 12th month after treatment