The objective of this trial is to assess the efficacy and safety of loading doses versus standard dose of intravenous Bondronat in reducing pain in patients with lung cancer and bone metastatic disease.
Patients with lung cancer and bone metastatic disease may experience moderate or severe bone pain. Some researches have reported that loading doses Bondronat (6mg Bondronat on three consecutive days) had great efficacy in reducing pain in patients with malignant bone disease without unacceptable toxicities. So,we designed this clinical trial to compare the efficacy and safety profiles between loading doses Bondronat and standard dose Bondronat.Enrolled patients will receive an intravenous infusion of either 6mg Bondronat on three consecutive days or 6mg Bondronat on one day. The targeted sample size is 120 individuals. Primary outcome measures will be bone pain response ( ≥ 25% decrease in mean pain score with a maximum of 15% increase in mean analgesic consumption). Secondary outcome measures will be efficacy including ECOG Performance status, analgesic consumption, bone markers, and safety profiles including AE and laboratory parameters.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Intravenous infusion of either 6mg Bondronat on three consecutive days or 6mg Bondronat on one day.
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Beijing Cancer Hospital
Beijing, China
Sun Yat-sen University Cancer Center
Guangzhou, China
bone pain response (≥25% decrease in mean pain score with a maximum of 15% increase in mean analgesic consumption)
Time frame: 1 month
Efficacy: ECOG Performance status, Analgesic consumption, bone marker Safety: AE, laboratory parameters
Time frame: 1 month
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The Tumor Hospital of Harbin Medical University
Harbin, China
Shanghai Chest Hospital
Shanghai, China
Shanghai Pulmonary Hospital
Shanghai, China
General Hospital of Tianjin Medical University
Tianjin, China