Clinical trial NCT00082927: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metastatic Cancer
Pain
Prostate Cancer
Keywords: stage IV prostate cancer
bone metastases
pain
recurrent prostate cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-05-19
Enrollment: 580
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: SUPPORTIVE_CARE

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.

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

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