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

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metastatic Cancer; Pain; Prostate Cancer

Intervention: ibandronate sodium (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Cancer Research UK

Official(s) and/or principal investigator(s):
Heather Purnell, Affiliation: Cancer Research UK
Katherine Monson, Affiliation: Cancer Research UK

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.

Clinical Details

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

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

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

William Harvey Hospital, Ashford-Kent, England TN24 0LZ, United Kingdom

North Devon District Hospital, Barnstaple, England EX31 4JB, United Kingdom

Basingstoke and North Hampshire NHS Foundation Trust, Basingstoke, England RG24 9NA, United Kingdom

Royal United Hospital, Bath, England BA1 3NG, United Kingdom

Sussex Cancer Centre at Royal Sussex County Hospital, Brighton, England BN2 5BF, United Kingdom

Bristol Haematology and Oncology Centre, Bristol, England BS2 8ED, United Kingdom

Queen's Hospital, Burton-upon-Trent, England DE13 0RB, United Kingdom

Kent and Canterbury Hospital, Canterbury, England CT1 3NG, United Kingdom

Cumberland Infirmary, Carlisle, England CA2 7HY, United Kingdom

Essex County Hospital, Colchester, England C03 3NB, United Kingdom

Walsgrave Hospital, Coventry, England CV2 2DX, United Kingdom

Mayday University Hospital, Croydon, England, United Kingdom

Russells Hall Hospital, Dudley, England DY1 2HQ, United Kingdom

Eastbourne District General Hospital, Eastbourne, England BN21 2UD, United Kingdom

Royal Devon and Exeter Hospital, Exeter, England EX2 5DW, United Kingdom

Diana Princess of Wales Hospital, Grimsby, England DN33 2BA, United Kingdom

St. Luke's Cancer Centre at Royal Surrey County Hospital, Guildford, England GU2 7XX, United Kingdom

Harrogate District Hospital, Harrogate, England HG2 7SX, United Kingdom

Kidderminster Hospital, Kidderminster Worcestershire, England DY11 6RJ, United Kingdom

Leeds Cancer Centre at St. James's University Hospital, Leeds, England LS9 7TF, United Kingdom

Lincoln County Hospital, Lincoln, England LN2 5QY, United Kingdom

Cancer Research UK and University College London Cancer Trials Centre, London, England NW1 2ND, United Kingdom

Charing Cross Hospital, London, England W6 8RF, United Kingdom

Royal Marsden - London, London, England SW3 6JJ, United Kingdom

St. Mary's Hospital, London, England W2 1NY, United Kingdom

Clatterbridge Centre for Oncology, Merseyside, England CH63 4JY, United Kingdom

Northampton General Hospital NHS Trust, Northampton, England NN1 5BD, United Kingdom

Mount Vernon Cancer Centre at Mount Vernon Hospital, Northwood, England HA6 2RN, United Kingdom

King's Mills Hospital, Nottinghamshire, England NG17 4JL, United Kingdom

Nottingham City Hospital NHS Trust, Nottingham, England NG5 1PB, United Kingdom

George Eliot Hospital, Nuneaton, England CV10 7DJ, United Kingdom

Alexandra Healthcare NHS, Redditch, Worcestershire, England B98 7UB, United Kingdom

Oldchurch Hospital, Romford, England RM7 OBE, United Kingdom

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

Scarborough General Hospital, Scarborough, England YO12 6QL, United Kingdom

Scunthorpe General Hospital, Scunthorpe, England DN15 7BH, United Kingdom

Royal Shrewsbury Hospital, Shrewsbury, England SY3 8XQ, United Kingdom

Southampton General Hospital, Southampton, England SO16 6YD, United Kingdom

Royal Marsden - Surrey, Sutton, England SM2 5PT, United Kingdom

Musgrove Park Hospital, Taunton, England TA1 5DA, United Kingdom

Torbay Hospital, Torquay, England TQ2 7AA, United Kingdom

Warrington Hospital NHS Trust, Warrington, England WA5 1QG, United Kingdom

Warwick Hospital, Warwick, England CV34 5BW, United Kingdom

Sandwell General Hospital, West Bromwich, England B71 4HJ, United Kingdom

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

West Cumberland Hospital, Whitehaven, England CA28 8JG, United Kingdom

New Cross Hospital, Wolverhampton, England WV10 0QP, United Kingdom

Worthing Hospital, Worthing, England BN11 2DH, United Kingdom

Yeovil District Hospital, Yeovil, England BA21 4AT, United Kingdom

Cancer Care Centre at York Hospital, York, England Y031 8HE, United Kingdom

Ninewells Hospital, Dundee, Scotland DD1 9SY, United Kingdom

Glan Clwyd Hospital, Rhyl, Denbighshire, Wales LL 18 5UJ, United Kingdom

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: April 2003
Last updated: June 25, 2013

Page last updated: August 23, 2015

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