A phase II trial of evaluating the benefit of zoledronic acid in non-small cell lung cancer patients with bone metastases and elevated marker of osteoclast activity.
Phase 2
Recruiting
- Conditions
- on-small cell lung cancer patients with bone metastases and elevated marker of osteoclast activity
- Registration Number
- JPRN-UMIN000005088
- Lead Sponsor
- ung Oncology Group in Kyushu, Japan (LOGIK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 55
Inclusion Criteria
Not provided
Exclusion Criteria
Patients who need radiotherapy or surgery immediately against bone metastases. Prior treatment with Sr-89. Prior bisphosphonates used for cancer. Patients with symptomatic brain metastasis. Severe odontopathy. Interstitial pneumonia on chest x-ray. Patients with active concomitant malignancy. Uncontrolled heart disease, hepatic disease, diabetes mellitus, bleeding. EGFR (+) and planned for EGFR-TKI treatment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients who developed SRE.
- Secondary Outcome Measures
Name Time Method 1.Time to first SRE 2.Safety 3.Progression free survival 4.Overall survival 5.Response rate 6.Rate of change of bone marker 7.Rate of change of pain score