|- candidate number||1826|
|- NTR Number||NTR503|
|- Date ISRCTN created||9-jan-2006|
|- date ISRCTN requested||13-dec-2005|
|- Date Registered NTR||14-nov-2005|
|- Secondary IDs||N/A |
|- Public Title||Radiotherapy with or without ibandronate in the treatment of painful bone metastases of prostate cancer.|
|- Scientific Title||Radiotherapy with or without ibandronate in the treatment of painful bone metastases of prostate cancer.|
|- hypothesis||The 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) studied||Prostate cancer, Metastasis|
|- Inclusion criteria||1. 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 criteria||1. 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 received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-dec-2005|
|- planned closingdate||1-dec-2007|
|- Target number of participants||80|
|- Interventions||Ibandronaat tablet or placebo.|
|- Primary outcome||Primary 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 outcome||Pain 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.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MD. PhD. L. Incrocci|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. L. Incrocci|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|Roche Nederland BV|
|- Brief summary||Although 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)|
|- RECORD||14-nov-2005 - 18-jan-2010|