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

Prostate Cancer Clinical Trial

Official title:

A Multicentre Randomised Trial Of Single Dose Radiotherapy Compared To Ibandronate For Localised Metastatic Bone Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00082927
• Other study ID #: CRUK-NCRI-RT-02-01
• Secondary ID: CDR0000361728EU-
• Status: Completed
• Phase: Phase 3
• First received: May 14, 2004
• Last updated: June 25, 2013
• Start date: April 2003
• Est. completion date: July 2011

Study information

• Verified date: June 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES:

Primary

• Compare pain response 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 (8Gy/1f).

• Arm II: Patients receive a single dose of ibandronate IV over 15 minutes. 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 and 12 months.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 470 patients (235 per treatment arm) will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 580
• Est. completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis
• Pain
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• ibandronate sodium

Locations

Country	Name	City	State
United Kingdom	William Harvey Hospital	Ashford-Kent	England
United Kingdom	North Devon District Hospital	Barnstaple	England
United Kingdom	Basingstoke and North Hampshire NHS Foundation Trust	Basingstoke	England
United Kingdom	Royal United Hospital	Bath	England
United Kingdom	Sussex Cancer Centre at Royal Sussex County Hospital	Brighton	England
United Kingdom	Bristol Haematology and Oncology Centre	Bristol	England
United Kingdom	Queen's Hospital	Burton-upon-Trent	England
United Kingdom	Kent and Canterbury Hospital	Canterbury	England
United Kingdom	Cumberland Infirmary	Carlisle	England
United Kingdom	Essex County Hospital	Colchester	England
United Kingdom	Walsgrave Hospital	Coventry	England
United Kingdom	Mayday University Hospital	Croydon	England
United Kingdom	Russells Hall Hospital	Dudley	England
United Kingdom	Ninewells Hospital	Dundee	Scotland
United Kingdom	Eastbourne District General Hospital	Eastbourne	England
United Kingdom	Royal Devon and Exeter Hospital	Exeter	England
United Kingdom	Diana Princess of Wales Hospital	Grimsby	England
United Kingdom	St. Luke's Cancer Centre at Royal Surrey County Hospital	Guildford	England
United Kingdom	Harrogate District Hospital	Harrogate	England
United Kingdom	Kidderminster Hospital	Kidderminster Worcestershire	England
United Kingdom	Leeds Cancer Centre at St. James's University Hospital	Leeds	England
United Kingdom	Lincoln County Hospital	Lincoln	England
United Kingdom	Cancer Research UK and University College London Cancer Trials Centre	London	England
United Kingdom	Charing Cross Hospital	London	England
United Kingdom	Royal Marsden - London	London	England
United Kingdom	St. Mary's Hospital	London	England
United Kingdom	Clatterbridge Centre for Oncology	Merseyside	England
United Kingdom	Northampton General Hospital NHS Trust	Northampton	England
United Kingdom	Mount Vernon Cancer Centre at Mount Vernon Hospital	Northwood	England
United Kingdom	Nottingham City Hospital NHS Trust	Nottingham	England
United Kingdom	King's Mills Hospital	Nottinghamshire	England
United Kingdom	George Eliot Hospital	Nuneaton	England
United Kingdom	Alexandra Healthcare NHS	Redditch, Worcestershire	England
United Kingdom	Glan Clwyd Hospital	Rhyl, Denbighshire	Wales
United Kingdom	Oldchurch Hospital	Romford	England
United Kingdom	Conquest Hospital	Saint Leonards-on-Sea	England
United Kingdom	Scarborough General Hospital	Scarborough	England
United Kingdom	Scunthorpe General Hospital	Scunthorpe	England
United Kingdom	Royal Shrewsbury Hospital	Shrewsbury	England
United Kingdom	Southampton General Hospital	Southampton	England
United Kingdom	Royal Marsden - Surrey	Sutton	England
United Kingdom	Musgrove Park Hospital	Taunton	England
United Kingdom	Torbay Hospital	Torquay	England
United Kingdom	Warrington Hospital NHS Trust	Warrington	England
United Kingdom	Warwick Hospital	Warwick	England
United Kingdom	Sandwell General Hospital	West Bromwich	England
United Kingdom	Weston General Hospital	Weston-super-Mare	England
United Kingdom	West Cumberland Hospital	Whitehaven	England
United Kingdom	New Cross Hospital	Wolverhampton	England
United Kingdom	Worthing Hospital	Worthing	England
United Kingdom	Yeovil District Hospital	Yeovil	England
United Kingdom	Cancer Care Centre at York Hospital	York	England

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Research UK

Country where clinical trial is conducted

United Kingdom,