Single-Dose Local Radiation Therapy Compared With Ibandronate in Treating Patients With Localized Metastatic Bone Pain

NCT00082927 | Completed Phase 3

• 5 other identifiers: CRUK-NCRI-RT-02-01CDR0000361728EU-20224RIBISRCTN86185157
• Study Type: interventional
• Target: 580
• Locations: 1 country
• Sites: 52

Brief Summary

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: This phase III randomized clinical trial is studying ibandronate to see how well it works compared to single-dose local radiation therapy in treating patients with localized metastatic bone pain.

Conditions

Metastatic Cancer; Pain; Prostate Cancer

Keywords

stage IV prostate cancer; bone metastases; pain; recurrent prostate cancer

Interventions

ibandronate sodium DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed primary prostate cancer 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 * Male 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 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cancer Research UK: lead

Study Sites (52)

William Harvey Hospital

Ashford-Kent, England, TN24 0LZ, United Kingdom

Location

North Devon District Hospital

Barnstaple, England, EX31 4JB, United Kingdom

Location

Basingstoke and North Hampshire NHS Foundation Trust

Basingstoke, England, RG24 9NA, United Kingdom

Location

Royal United Hospital

Bath, England, BA1 3NG, United Kingdom

Location

Sussex Cancer Centre at Royal Sussex County Hospital

Brighton, England, BN2 5BF, United Kingdom

Location

Bristol Haematology and Oncology Centre

Bristol, England, BS2 8ED, United Kingdom

Location

Queen's Hospital

Burton-on-Trent, England, DE13 0RB, United Kingdom

Location

Kent and Canterbury Hospital

Canterbury, England, CT1 3NG, United Kingdom

Location

Cumberland Infirmary

Carlisle, England, CA2 7HY, United Kingdom

Location

Essex County Hospital

Colchester, England, C03 3NB, United Kingdom

Location

Walsgrave Hospital

Coventry, England, CV2 2DX, United Kingdom

Location

Mayday University Hospital

Croydon, England, United Kingdom

Location

Russells Hall Hospital

Dudley, England, DY1 2HQ, United Kingdom

Location

Eastbourne District General Hospital

Eastbourne, England, BN21 2UD, United Kingdom

Location

Royal Devon and Exeter Hospital

Exeter, England, EX2 5DW, United Kingdom

Location

Diana Princess of Wales Hospital

Grimsby, England, DN33 2BA, United Kingdom

Location

St. Luke's Cancer Centre at Royal Surrey County Hospital

Guildford, England, GU2 7XX, United Kingdom

Location

Harrogate District Hospital

Harrogate, England, HG2 7SX, United Kingdom

Location

Kidderminster Hospital

Kidderminster Worcestershire, England, DY11 6RJ, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Lincoln County Hospital

Lincoln, England, LN2 5QY, United Kingdom

Location

Cancer Research UK and University College London Cancer Trials Centre

London, England, NW1 2ND, United Kingdom

Location

Royal Marsden - London

London, England, SW3 6JJ, United Kingdom

Location

St. Mary's Hospital

London, England, W2 1NY, United Kingdom

Location

Charing Cross Hospital

London, England, W6 8RF, United Kingdom

Location

Clatterbridge Centre for Oncology

Merseyside, England, CH63 4JY, United Kingdom

Location

Northampton General Hospital NHS Trust

Northampton, England, NN1 5BD, United Kingdom

Location

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

Location

Nottingham City Hospital NHS Trust

Nottingham, England, NG5 1PB, United Kingdom

Location

King's Mills Hospital

Nottinghamshire, England, NG17 4JL, United Kingdom

Location

George Eliot Hospital

Nuneaton, England, CV10 7DJ, United Kingdom

Location

Alexandra Healthcare NHS

Redditch, Worcestershire, England, B98 7UB, United Kingdom

Location

Oldchurch Hospital

Romford, England, RM7 OBE, United Kingdom

Location

Conquest Hospital

Saint Leonards-on-Sea, England, TN37 7RD, United Kingdom

Location

Scarborough General Hospital

Scarborough, England, YO12 6QL, United Kingdom

Location

Scunthorpe General Hospital

Scunthorpe, England, DN15 7BH, United Kingdom

Location

Royal Shrewsbury Hospital

Shrewsbury, England, SY3 8XQ, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Musgrove Park Hospital

Taunton, England, TA1 5DA, United Kingdom

Location

Torbay Hospital

Torquay, England, TQ2 7AA, United Kingdom

Location

Warrington Hospital NHS Trust

Warrington, England, WA5 1QG, United Kingdom

Location

Warwick Hospital

Warwick, England, CV34 5BW, United Kingdom

Location

Sandwell General Hospital

West Bromwich, England, B71 4HJ, United Kingdom

Location

Weston General Hospital

Weston-super-Mare, England, BS23 4TQ, United Kingdom

Location

West Cumberland Hospital

Whitehaven, England, CA28 8JG, United Kingdom

Location

New Cross Hospital

Wolverhampton, England, WV10 0QP, United Kingdom

Location

Worthing Hospital

Worthing, England, BN11 2DH, United Kingdom

Location

Yeovil District Hospital

Yeovil, England, BA21 4AT, United Kingdom

Location

Cancer Care Centre at York Hospital

York, England, Y031 8HE, United Kingdom

Location

Ninewells Hospital

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Glan Clwyd Hospital

Rhyl, Denbighshire, Wales, LL 18 5UJ, United Kingdom

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Pain; Prostatic Neoplasms

Interventions

Ibandronic Acid

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Officials

• Heather Purnell

  Cancer Research UK

• Katherine Monson

  Cancer Research UK

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 14, 2004
• First Posted: May 19, 2004
• Study Start: April 1, 2003
• Study Completion: July 1, 2011
• Last Updated: June 26, 2013

Record last verified: 2009-06

Locations

GB (52)