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Palliative therapy of bone metastases by Radiopharmaceuticals

Phase 2
Conditions
Condition 1: Bone metastasis. Condition 2: Malignant neoplasms.
Malignant neoplasm of bone and articular cartilage of limbs
Malignant neoplasm of bone and articular cartilage of other and unspecified sites
Registration Number
IRCT201109181100N3
Lead Sponsor
Vice chancellor for research, Tehran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
20
Inclusion Criteria

Inclusion Criteria: Patients (>20 yr) with multiple skeletal metastasis of a known cancer who have intractable bone pain; Multiple painful bone metastases; Positive bone scan (within 6 wk); abnormal uptake (>1 site) corresponding to pain sites; Estimated life expectancy 2 months especially for agents with longer half-life; No chemotherapy or external beam radiation during 4-6 weeks before therapy with agent (This is particularly important when long-acting agents such as nitrosoureas have been given); WBC>2500 (some reports 3500); Platelet>60,000.

Exclusion Criteria

Acute or chronic renal failure; Acute spinal cord suppression; who need to external radiation therapy; A solitary metastatic site; Extensive soft tissue metastases; Evidence of disseminated intravascular coagulopathy; Prior to myelosuppressive chemotherapy; Impending pathologic fracture; Hemoglobin < 90 g.L-1; Total white cell count < 2500 (some reports 3500); Absolute neutrophil count < 1500; Platelets < 60,000; Glomerular filtration rate < 30 mL/min; Pregnancy; breastfeeding; women of child-bearing age.

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Bone pain. Timepoint: 2, 4 and 8 weeks elapsed from intervention. Method of measurement: Standardized questionaire.
Secondary Outcome Measures
NameTimeMethod
Bone marrow suppression. Timepoint: 2, 4 and 8 weeks elapsed from intervension. Method of measurement: Peripheral cell blood count.
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