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Single-Dose Local Radiation Therapy Compared With Ibandronate in Treating Patients With Localized Metastatic Bone Pain Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Single-Dose Local Radiation Therapy Compared With Ibandronate in Treating Patients With Localized Metastatic Bone Pain conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Single-Dose Local Radiation Therapy Compared With Ibandronate in Treating Patients With Localized Metastatic Bone Pain Clinical research trials and Single-Dose Local Radiation Therapy Compared With Ibandronate in Treating Patients With Localized Metastatic Bone Pain medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Single-Dose Local Radiation Therapy Compared With Ibandronate in Treating Patients With Localized Metastatic Bone Pain. Single-Dose Local Radiation Therapy Compared With Ibandronate in Treating Patients With Localized Metastatic Bone Pain Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Single-Dose Local Radiation Therapy Compared With Ibandronate in Treating Patients With Localized Metastatic Bone Pain clinical trial. Participants frequently get the best healthcare available for their Single-Dose Local Radiation Therapy Compared With Ibandronate in Treating Patients With Localized Metastatic Bone Pain condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Single-Dose Local Radiation Therapy Compared With Ibandronate in Treating Patients With Localized Metastatic Bone Pain  Single-Dose Local Radiation Therapy Compared With Ibandronate in Treating Patients With Localized Metastatic Bone Pain
Single-Dose Local Radiation Therapy Compared With Ibandronate in Treating Patients With Localized Metastatic Bone Pain
For Condition: Pain,Lung Cancer,metastatic cancer,Prostate Cancer,Breast Cancer
Status: Recruiting
Sponsor(s): Cancer Research UK and University College London Cancer Trials Unit ,
Synopsis: RATIONALE: Ibandronate may be effective in reducing bone pain caused by metastatic cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether ibandronate is more effective than standard treatment with radiation therapy in treating metastatic bone pain. PURPOSE: Randomized clinical trial to compare the effectiveness of ibandronate with that of single-doselocal radiation therapy in treating patients who have localized metastatic bone pain.
Details: OBJECTIVES: Primary - Compare pain control at 4 and 12 weeks post-treatment in patients with localized metastatic bone pain treated with single-dose ibandronate vs single-dose local radiotherapy . Secondary - Compare the quality of life of patients treated with these regimens. - Correlate urinary markers of osteoclast activity (pyridinoline and deoxypyridinoline) with the clinical outcome of patients treated with these regimens. OUTLINE: This is a randomized, open-label, crossover, multicenter study. Patients are stratified according to primary tumor type and participating center. Patients are randomized into 1 of 2 treatment arms. - Arm I: Patients receive a single dose of local radiotherapy to the site of pain. - Arm II: Patients receive a single dose of ibandronate IV over 1-2 hours. Patients who do not achieve a partial or complete response at 4 weeks crossover to the alternate arm. Quality of life is assessed at baseline and then at 4 and 12 weeks. Pain is assessed at baseline, at 4, 8, and 12 weeks, and then at 6 months. Patients are followed at 4, 8, and 12 weeks and then at 6 months. PROJECTED ACCRUAL: A total of 580 patients (290 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed primary malignancy of the breast, lung, or prostate OR sclerotic bone metastases (for patients with serum prostate-specific antigen > 100 ng/mL) - Radiologically confirmed bone metastases by plain x-ray, isotope scan, CT scan, or MRI - Clinical diagnosis of metastatic bone pain for which radiotherapy is indicated - Single localized metastatic bone pain AND receiving optimal analgesics and adjuvant drugs, including non-steroidal anti-inflammatory drugs, unless contraindicated - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - Over 18 Sex - Not specified Menopausal status - Not specified Performance status - Not specified Life expectancy - At least 3 months Hematopoietic - Not specified Hepatic - Not specified Renal - Creatinine 3.0 mg/dL - No hypercalcemia (corrected calcium > 10.8 mg/dL) - No hypocalcemia (corrected calcium < 8.2 mg/dL) Other - No known hypersensitivity to ibandronate or other bisphosphonates - No history of aspirin-sensitive asthma - Able to comply with pain chart and quality of life assessments - Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - More than 4 weeks since prior change in systemic chemotherapy - No prior high-dose chemotherapy (dose intensity > 3 times standard dose) Endocrine therapy - More than 4 weeks since prior change in hormonal therapy Radiotherapy - See Disease Characteristics - No prior external beam radiotherapy to index site - No prior systemic radioisotope therapy (e.g., strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium) Surgery - Not specified Other - More than 6 months since prior bisphosphonate treatment - More than 4 weeks since prior aminoglycoside antibiotics - More than 30 days since prior investigational drugs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
OrlaCummins, Study Chair, Cancer Research UK and University College London Cancer Trials Unit
Charing Cross Hospital *Recruiting*
London, England, W6 8RF
United Kingdom
Recruiting Simon Stewart 44-20-8846-7659
Derbyshire Royal Infirmary *Recruiting*
Derby, England, DE1 2QY
United Kingdom
Recruiting Pamela Woodings 01-332-347-141 ext. 4575
Churchill Hospital *Recruiting*
Oxford, England, OX3 7LJ
United Kingdom
Recruiting C. Alcock 44-186-574-1841
Clatterbridge Centre for Oncology NHS Trust *Recruiting*
Merseyside, England, CH63 4JY
United Kingdom
Recruiting I. Syndikus 44-151-334-1155
Hammersmith Hospital *Recruiting*
London, England, W12 ONN
United Kingdom
Recruiting Clare Vernon 44-171-740-3177
Ealing Hospital NHS Trust *Recruiting*
Southall Middlesex, England, UB1 3HW
United Kingdom
Recruiting C. Lewanski 44-020-8967-5000
Northern Centre for Cancer Treatment at Newcastle General Hospital *Recruiting*
Newcastle upon Tyne, England, NE4 6BE
United Kingdom
Recruiting P. Atherton 44-191-219-4200
Royal Surrey County Hospital *Recruiting*
Guildford, England, GU2 5XX
United Kingdom
Recruiting Marianne Illsley 44-1483-406-767
Walsgrave Hospital *Recruiting*
Coventry, England, CV2 2DX
United Kingdom
Recruiting Robert Grieve 24-76-535-020
Derriford Hospital *Recruiting*
Plymouth, England, PL6 8DH
United Kingdom
Recruiting C.J. Tyrrell 44-075-283-4519
Mount Vernon Hospital *Recruiting*
Northwood, England, HA6 2RN
United Kingdom
Recruiting Peter Hoskin 44-019-2384-4533
Princess Royal Hospital *Recruiting*
Hull, England, HU8 9HE
United Kingdom
Recruiting M.J. Lind 44-482-676-736
Oldchurch Hospital *Recruiting*
Romford, England, RM7 OBE
United Kingdom
Recruiting Alsafer 44-1708-746-090
Ipswich Hospital NHS Trust *Recruiting*
Ipswich, England, IP4 5PD
United Kingdom
Recruiting John Vay 44-014-7371-2233
Alexandra Healthcare NHS *Recruiting*
Redditch, Worcestershire, England, B98 7UB
United Kingdom
Recruiting C. Irwin 44-015-2750-3030
Royal Sussex County Hospital *Recruiting*
Brighton, England, BN2 5BF
United Kingdom
Recruiting David Bloomfield 44-1273-696-955 ext. 7686
St. Mary's Hospital *Recruiting*
London, England, W2 1NY
United Kingdom
Recruiting Carmel Coulter 44-020-7886-6000
Weston Park Hospital *Recruiting*
Sheffield, England, S1O 2SJ
United Kingdom
Recruiting O.P. Purohit 44-114-226-5000
George Eliot Hospital *Recruiting*
Nuneaton, England, CV10 7DJ
United Kingdom
Recruiting Hocking 44-024-7635-1351
Nottingham City Hospital NHS Trust *Recruiting*
Nottingham, England, NG5 1PB
United Kingdom
Recruiting Michael Sokal 44-115-969-1169
Royal Marsden Hospital - Sutton *Recruiting*
Sutton, England, SM2 5PT
United Kingdom
Recruiting Alan Horwich 44-20-8661-3274
Southampton General Hospital *Recruiting*
Southampton, England, SO16 6YD
United Kingdom
Recruiting Tom Illidge 44-23-8079-8751
Northwick Park Hospital *Recruiting*
Harrow, England, HA1 3UJ
United Kingdom
Recruiting Jane Maher 44-20-864-3232
Portsmouth Oncology Centre at Saint Mary's Hospital *Recruiting*
Portsmouth Hants, England, PO3 6AD
United Kingdom
Recruiting Jean Dubois 44-23-9228-6000
Saint Bartholomew's Hospital *Recruiting*
London, England, EC1A 7BE
United Kingdom
Recruiting Melanie Powell 44-20-7601-8391
Leicester Royal Infirmary *Recruiting*
Leicester, England, LE1 5WW
United Kingdom
Recruiting G.D. Thomas 44-116-258-6217
Addenbrooke's NHS Trust *Recruiting*
Cambridge, England, CB2 2QQ
United Kingdom
Recruiting Margaret Moody 44-1223-245-151
Velindre Cancer Center at Velinde Hospital *Recruiting*
Cardiff, Wales, CF14 2TL
United Kingdom
Recruiting Peter Barrett Lee 44-29-2061-5888
Lincoln County Hospital *Recruiting*
Lincoln, England, LN2 5QY
United Kingdom
Recruiting T. Sreenivasant 44-1522-573-965
Pilgrim Hospital *Recruiting*
Boston, England, PE21 9QT
United Kingdom
Recruiting Elisabeth Murray 44-1205-364-801
Royal Devon and Exeter Hospital *Recruiting*
Exeter, England, EX2 5DW
United Kingdom
Recruiting Denise Sheehan 44-1392-411-611
Cancer Research UK and University College London Cancer Trials Unit *Recruiting*
London, England, NW1 2ND
United Kingdom
Recruiting Orla Cummins 44-207-679-8036
Additional Information:
Study ID Numbers: CDR0000361728; ISRCTN86185157,CRUK-NCRI-RT-02-01,RIB,EU-20224
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00082927
Other Metastatic Cancer Studies:
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2. Phase II trial of oral study drug in patients with advanced metastatic breast cancer who have experienced failure of an anthracycline, a taxane, and capecitabine
3. Acupressure in Treating Nausea in Women Receiving Combination Chemotherapy for Breast Cancer
4. Bexarotene in Preventing Breast Cancer in Women at Genetic Risk
5. Amifostine Followed by High Dose Chemotherapy in Treating Patients With Hematologic Cancer or Solid Tumors
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Single-Dose Local Radiation Therapy Compared With Ibandronate in Treating Patients With Localized Metastatic Bone Pain
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