Back to resultsSingle-Dose Local Radiation Therapy Compared With Ibandronate in Treating Patients With Localized Metastatic Bone Pain
Primary Purpose
Metastatic Cancer, Pain, Prostate Cancer
Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
ibandronate sodium
Sponsored by
About this trial
This is an interventional supportive care trial for Metastatic Cancer focused on measuring stage IV prostate cancer, bone metastases, pain, recurrent prostate cancer
Eligibility Criteria
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
Sites / Locations
- William Harvey Hospital
- North Devon District Hospital
- Basingstoke and North Hampshire NHS Foundation Trust
- Royal United Hospital
- Sussex Cancer Centre at Royal Sussex County Hospital
- Bristol Haematology and Oncology Centre
- Queen's Hospital
- Kent and Canterbury Hospital
- Cumberland Infirmary
- Essex County Hospital
- Walsgrave Hospital
- Mayday University Hospital
- Russells Hall Hospital
- Eastbourne District General Hospital
- Royal Devon and Exeter Hospital
- Diana Princess of Wales Hospital
- St. Luke's Cancer Centre at Royal Surrey County Hospital
- Harrogate District Hospital
- Kidderminster Hospital
- Leeds Cancer Centre at St. James's University Hospital
- Lincoln County Hospital
- Cancer Research UK and University College London Cancer Trials Centre
- Royal Marsden - London
- St. Mary's Hospital
- Charing Cross Hospital
- Clatterbridge Centre for Oncology
- Northampton General Hospital NHS Trust
- Mount Vernon Cancer Centre at Mount Vernon Hospital
- King's Mills Hospital
- Nottingham City Hospital NHS Trust
- George Eliot Hospital
- Alexandra Healthcare NHS
- Oldchurch Hospital
- Conquest Hospital
- Scarborough General Hospital
- Scunthorpe General Hospital
- Royal Shrewsbury Hospital
- Southampton General Hospital
- Royal Marsden - Surrey
- Musgrove Park Hospital
- Torbay Hospital
- Warrington Hospital NHS Trust
- Warwick Hospital
- Sandwell General Hospital
- Weston General Hospital
- West Cumberland Hospital
- New Cross Hospital
- Worthing Hospital
- Yeovil District Hospital
- Cancer Care Centre at York Hospital
- Ninewells Hospital
- Glan Clwyd Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00082927
Brief Title
Single-Dose Local Radiation Therapy Compared With Ibandronate in Treating Patients With Localized Metastatic Bone Pain
Official Title
A Multicentre Randomised Trial Of Single Dose Radiotherapy Compared To Ibandronate For Localised Metastatic Bone Pain
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cancer Research UK
4. Oversight
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer, Pain, Prostate Cancer
Keywords
stage IV prostate cancer, bone metastases, pain, recurrent prostate cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Randomized
Enrollment
580 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ibandronate sodium
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Purnell
Organizational Affiliation
Cancer Research UK
First Name & Middle Initial & Last Name & Degree
Katherine Monson
Organizational Affiliation
Cancer Research UK
Facility Information:
Facility Name
William Harvey Hospital
City
Ashford-Kent
State/Province
England
ZIP/Postal Code
TN24 0LZ
Country
United Kingdom
Facility Name
North Devon District Hospital
City
Barnstaple
State/Province
England
ZIP/Postal Code
EX31 4JB
Country
United Kingdom
Facility Name
Basingstoke and North Hampshire NHS Foundation Trust
City
Basingstoke
State/Province
England
ZIP/Postal Code
RG24 9NA
Country
United Kingdom
Facility Name
Royal United Hospital
City
Bath
State/Province
England
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
Sussex Cancer Centre at Royal Sussex County Hospital
City
Brighton
State/Province
England
ZIP/Postal Code
BN2 5BF
Country
United Kingdom
Facility Name
Bristol Haematology and Oncology Centre
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Queen's Hospital
City
Burton-upon-Trent
State/Province
England
ZIP/Postal Code
DE13 0RB
Country
United Kingdom
Facility Name
Kent and Canterbury Hospital
City
Canterbury
State/Province
England
ZIP/Postal Code
CT1 3NG
Country
United Kingdom
Facility Name
Cumberland Infirmary
City
Carlisle
State/Province
England
ZIP/Postal Code
CA2 7HY
Country
United Kingdom
Facility Name
Essex County Hospital
City
Colchester
State/Province
England
ZIP/Postal Code
C03 3NB
Country
United Kingdom
Facility Name
Walsgrave Hospital
City
Coventry
State/Province
England
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Mayday University Hospital
City
Croydon
State/Province
England
Country
United Kingdom
Facility Name
Russells Hall Hospital
City
Dudley
State/Province
England
ZIP/Postal Code
DY1 2HQ
Country
United Kingdom
Facility Name
Eastbourne District General Hospital
City
Eastbourne
State/Province
England
ZIP/Postal Code
BN21 2UD
Country
United Kingdom
Facility Name
Royal Devon and Exeter Hospital
City
Exeter
State/Province
England
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Diana Princess of Wales Hospital
City
Grimsby
State/Province
England
ZIP/Postal Code
DN33 2BA
Country
United Kingdom
Facility Name
St. Luke's Cancer Centre at Royal Surrey County Hospital
City
Guildford
State/Province
England
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Harrogate District Hospital
City
Harrogate
State/Province
England
ZIP/Postal Code
HG2 7SX
Country
United Kingdom
Facility Name
Kidderminster Hospital
City
Kidderminster Worcestershire
State/Province
England
ZIP/Postal Code
DY11 6RJ
Country
United Kingdom
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Lincoln County Hospital
City
Lincoln
State/Province
England
ZIP/Postal Code
LN2 5QY
Country
United Kingdom
Facility Name
Cancer Research UK and University College London Cancer Trials Centre
City
London
State/Province
England
ZIP/Postal Code
NW1 2ND
Country
United Kingdom
Facility Name
Royal Marsden - London
City
London
State/Province
England
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
St. Mary's Hospital
City
London
State/Province
England
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Facility Name
Charing Cross Hospital
City
London
State/Province
England
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Clatterbridge Centre for Oncology
City
Merseyside
State/Province
England
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
Northampton General Hospital NHS Trust
City
Northampton
State/Province
England
ZIP/Postal Code
NN1 5BD
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre at Mount Vernon Hospital
City
Northwood
State/Province
England
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
King's Mills Hospital
City
Nottinghamshire
State/Province
England
ZIP/Postal Code
NG17 4JL
Country
United Kingdom
Facility Name
Nottingham City Hospital NHS Trust
City
Nottingham
State/Province
England
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
George Eliot Hospital
City
Nuneaton
State/Province
England
ZIP/Postal Code
CV10 7DJ
Country
United Kingdom
Facility Name
Alexandra Healthcare NHS
City
Redditch, Worcestershire
State/Province
England
ZIP/Postal Code
B98 7UB
Country
United Kingdom
Facility Name
Oldchurch Hospital
City
Romford
State/Province
England
ZIP/Postal Code
RM7 OBE
Country
United Kingdom
Facility Name
Conquest Hospital
City
Saint Leonards-on-Sea
State/Province
England
ZIP/Postal Code
TN37 7RD
Country
United Kingdom
Facility Name
Scarborough General Hospital
City
Scarborough
State/Province
England
ZIP/Postal Code
YO12 6QL
Country
United Kingdom
Facility Name
Scunthorpe General Hospital
City
Scunthorpe
State/Province
England
ZIP/Postal Code
DN15 7BH
Country
United Kingdom
Facility Name
Royal Shrewsbury Hospital
City
Shrewsbury
State/Province
England
ZIP/Postal Code
SY3 8XQ
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Royal Marsden - Surrey
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Musgrove Park Hospital
City
Taunton
State/Province
England
ZIP/Postal Code
TA1 5DA
Country
United Kingdom
Facility Name
Torbay Hospital
City
Torquay
State/Province
England
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
Facility Name
Warrington Hospital NHS Trust
City
Warrington
State/Province
England
ZIP/Postal Code
WA5 1QG
Country
United Kingdom
Facility Name
Warwick Hospital
City
Warwick
State/Province
England
ZIP/Postal Code
CV34 5BW
Country
United Kingdom
Facility Name
Sandwell General Hospital
City
West Bromwich
State/Province
England
ZIP/Postal Code
B71 4HJ
Country
United Kingdom
Facility Name
Weston General Hospital
City
Weston-super-Mare
State/Province
England
ZIP/Postal Code
BS23 4TQ
Country
United Kingdom
Facility Name
West Cumberland Hospital
City
Whitehaven
State/Province
England
ZIP/Postal Code
CA28 8JG
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
State/Province
England
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
Facility Name
Worthing Hospital
City
Worthing
State/Province
England
ZIP/Postal Code
BN11 2DH
Country
United Kingdom
Facility Name
Yeovil District Hospital
City
Yeovil
State/Province
England
ZIP/Postal Code
BA21 4AT
Country
United Kingdom
Facility Name
Cancer Care Centre at York Hospital
City
York
State/Province
England
ZIP/Postal Code
Y031 8HE
Country
United Kingdom
Facility Name
Ninewells Hospital
City
Dundee
State/Province
Scotland
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Glan Clwyd Hospital
City
Rhyl, Denbighshire
State/Province
Wales
ZIP/Postal Code
LL 18 5UJ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Single-Dose Local Radiation Therapy Compared With Ibandronate in Treating Patients With Localized Metastatic Bone Pain
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