![]() Results: Of the 19 enrolled patients in the first stage, 18 were evaluable for response. Secondary endpoints: BPI score, quality of life, toxicity and World Health Organization Performance Score. Primary endpoint: bone pain response, defined as 25% decrease in worst pain score (PSc) over a 3-day period (day 5–7) compared to baseline PSc with maximum of 25% increase in mean analgesic consumption during the same period. ![]() If pain response is observed in ≤ 12 of the first 19 patients further enrollment will be stopped. Statistics: Simon's Optimal two-stage design with a 90% power to declare the treatment active if the pain response rate is ≥ 80% and 95% confidence to declare the treatment inactive if the pain response rate is ≤ 60%. Main exclusion criteria: active secondary malignancy, systemic anti-tumor treatment and radiotherapy ≤4 weeks before study start, previous bisphosphonate treatment. Patients were treated with six milligram ibandronate intravenously (day 1–3) once a day. Main inclusion criterion: bone metastasized NSCLC patients with uncontrolled CIBP ≥ 5 over last 7 days]. Methods: The NVALT-9 was an open-label, single arm, phase II, multicenter study. Introduction: Approximately 80% of non-small cell lung cancer (NSCLC) patients with bone metastases have cancer induced bone pain (CIBP). 9Department of Pulmonary Diseases, Erasmus MC, Rotterdam, Netherlands.8Department of Pulmonary Diseases, Rijnstate Hospital, Arnhem, Netherlands.7Department of Pulmonary Diseases, Jeroen Bosch Hospital, ‘s-Hertogenbosch, Netherlands.6Department of Pulmonary Diseases, University Medical Center Groningen, Groningen, Netherlands.5Department of Pulmonary Diseases, St. ![]()
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