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Radiotherapy with or without ibandronate in the treatment of painful bone metastases of prostate cancer.


- candidate number1826
- NTR NumberNTR503
- ISRCTNISRCTN55471205
- Date ISRCTN created9-jan-2006
- date ISRCTN requested13-dec-2005
- Date Registered NTR14-nov-2005
- Secondary IDsN/A 
- Public TitleRadiotherapy with or without ibandronate in the treatment of painful bone metastases of prostate cancer.
- Scientific TitleRadiotherapy with or without ibandronate in the treatment of painful bone metastases of prostate cancer.
- ACRONYMN/A
- hypothesisThe purpose of this study is to evaluate the efficacy of oral ibandronate (versus placebo) added to the standard radiotherapy regimen for painful bone metastases to reduce pain, to reduce the need of analgesics, and to reduce skeletal-related events (impending fractures, need of repeated radiotherapy, or surgery).
- Healt Condition(s) or Problem(s) studiedProstate cancer, Metastasis
- Inclusion criteria1. Karnofsky score Ąd60%;
2. Written informed consent;
3. Histologically proven PC with documented (bone scintigraphy, CT scan, MRI, or conventional X-Ray) bone metastases, without spinal cord/cauda equina compression;
4. Indication for analgesic radiotherapy;
5. Estimated life expectancy of Ąd6 months;
6. Clinically documented painful bone metastases;
7. Indication for analgesic radiotherapy for the painful bone metastases.
- Exclusion criteria1. Previous treatment with any kind of bisphosphonates or radionuclides;
2. Hypercalcemia (serum calcium level >2.65 mmol/L), hypocalcemia (serum calcium level <2.2 mmol/L), impaired renal function (creatinine >266 umol/L; albumin >50 g/L), according to the medical charts;
3. Investigational drugs within 30 days before study entry;
4. Paget°¶s disease;
5. Untreated esophagitis or gastric ulcer.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2005
- planned closingdate1-dec-2007
- Target number of participants80
- InterventionsIbandronaat tablet or placebo.
- Primary outcomePrimary objective will be pain reduction on the pain scale (scale 0-10) at 12 weeks of treatment. Response of treatment will be defined as a reduction of at least two points of the pain scale.
- Secondary outcomePain reduction on the pain scale at 4-8-16-20-24 weeks of treatment. Use of analgesics at 4-8-12-16-20-24 weeks of treatment.
New skeletal-related events (=time to progression, including fractures, need of repeated radiotherapy, surgery).
Side effects at 4-8-12-16-20-24 weeks of treatment.
Quality of Life, as measured by the EORTC-QLQ-C30 and EQ-5D, at 12-24 weeks.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD. PhD. L. Incrocci
- CONTACT for SCIENTIFIC QUERIESMD. PhD. L. Incrocci
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Roche Nederland BV
- PublicationsN/A
- Brief summaryAlthough radiotherapy is highly effective to treat painful bone metastases of PC, the rate of re-treatment is considerable, and re-treatment of the same metastases needs to be done often after a short time and with a low response rate.
Ibandronate, 50 mg administered on a daily base for 6 months, might be effective to reduce pain from bone metastases, to reduce the need of analgesics, and to reduce the need of re-treatments with radiotherapy or other interventions.
- Main changes (audit trail)
- RECORD14-nov-2005 - 18-jan-2010


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