Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT00264420
Eligibility Criteria:
Inclusion Criteria:
* \>18 years of age
* biopsy proven breast, lung, and/or prostate cancer
* boney metastases with an indication for radiation, either diagnosed radiologically or biopsy proven
* Karnofsky Performance Status \>60
* Life expectancy of at least 6 months
* Serum creatinine level ≤ 2.0 mg/dL and calculated creatinine clearance of \> 60 mL/min
* Leukocyte count ≥ 3500/mm3
* Hemoglobulin \> 11 g/dl
* Platelets \> 100,000 / mm3
* Total bilirubin \< 2.5 mg/dl
Exclusion Criteria:
* pregnant and lactating women (breast and lung cancer)
* hormonotherapy started less than 3 months prior to randomization (prostate cancer)
* history of allergic reactions to bisphosphonates
* receiving concomitant nephrotoxic chemotherapy
* participation in another clinical trial with an investigational drug or completed an investigational drug trial within the past 30 days
* liver function tests \> 1.5 times normal values
* IV calcitonin administration less than 30 days prior to randomization
* laboratory evidence of renal disease
* previous RT to the region of bone metastasis which will be treated in this study
* currently receiving oral or IV bisphosphonate therapy
* presence of ascites
* clinically significant electrocardiographic changes
* hypercalcemia, pathologic fracture, or epidural spinal cord compression
* other organ metastasis
* known hypersensitivity to Zometa® (zoledronic acid) or other bisphosphonates
* current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
* recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction, implants)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00264420
Study Brief:
Protocol Section:
NCT00264420