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Metastatic CancerPhase 3NCT00082927

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

A Phase 3 study testing ibandronate sodium in people with Metastatic Cancer and Pain, run by Cancer Research UK at 52 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Cancer, Pain, Prostate Cancer
What is being tested?
ibandronate sodium
How many people
580 participants
Where
52 sitesUnited Kingdom
Study dates
Apr 2003to Jul 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

52 sites in 1 country.

52 sites in 1 country

United Kingdom52 sites

  • William Harvey Hospital

    Ashford-Kent, England, TN24 0LZ

  • North Devon District Hospital

    Barnstaple, England, EX31 4JB

  • Basingstoke and North Hampshire NHS Foundation Trust

    Basingstoke, England, RG24 9NA

  • Royal United Hospital

    Bath, England, BA1 3NG

  • Sussex Cancer Centre at Royal Sussex County Hospital

    Brighton, England, BN2 5BF

  • Bristol Haematology and Oncology Centre

    Bristol, England, BS2 8ED

  • Queen's Hospital

    Burton-on-Trent, England, DE13 0RB

  • Kent and Canterbury Hospital

    Canterbury, England, CT1 3NG

  • Cumberland Infirmary

    Carlisle, England, CA2 7HY

  • Essex County Hospital

    Colchester, England, C03 3NB

  • Walsgrave Hospital

    Coventry, England, CV2 2DX

  • Mayday University Hospital

    Croydon, England

  • Russells Hall Hospital

    Dudley, England, DY1 2HQ

  • Ninewells Hospital

    Dundee, Scotland, DD1 9SY

  • Eastbourne District General Hospital

    Eastbourne, England, BN21 2UD

  • Royal Devon and Exeter Hospital

    Exeter, England, EX2 5DW

  • Diana Princess of Wales Hospital

    Grimsby, England, DN33 2BA

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

    Guildford, England, GU2 7XX

  • Harrogate District Hospital

    Harrogate, England, HG2 7SX

  • Kidderminster Hospital

    Kidderminster Worcestershire, England, DY11 6RJ

  • Leeds Cancer Centre at St. James's University Hospital

    Leeds, England, LS9 7TF

  • Lincoln County Hospital

    Lincoln, England, LN2 5QY

  • Cancer Research UK and University College London Cancer Trials Centre

    London, England, NW1 2ND

  • Royal Marsden - London

    London, England, SW3 6JJ

  • St. Mary's Hospital

    London, England, W2 1NY

  • Charing Cross Hospital

    London, England, W6 8RF

  • Clatterbridge Centre for Oncology

    Merseyside, England, CH63 4JY

  • Northampton General Hospital NHS Trust

    Northampton, England, NN1 5BD

  • Mount Vernon Cancer Centre at Mount Vernon Hospital

    Northwood, England, HA6 2RN

  • Nottingham City Hospital NHS Trust

    Nottingham, England, NG5 1PB

  • King's Mills Hospital

    Nottinghamshire, England, NG17 4JL

  • George Eliot Hospital

    Nuneaton, England, CV10 7DJ

  • Alexandra Healthcare NHS

    Redditch, Worcestershire, England, B98 7UB

  • Glan Clwyd Hospital

    Rhyl, Denbighshire, Wales, LL 18 5UJ

  • Oldchurch Hospital

    Romford, England, RM7 OBE

  • Conquest Hospital

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

  • Scarborough General Hospital

    Scarborough, England, YO12 6QL

  • Scunthorpe General Hospital

    Scunthorpe, England, DN15 7BH

  • Royal Shrewsbury Hospital

    Shrewsbury, England, SY3 8XQ

  • Southampton General Hospital

    Southampton, England, SO16 6YD

  • Royal Marsden - Surrey

    Sutton, England, SM2 5PT

  • Musgrove Park Hospital

    Taunton, England, TA1 5DA

  • Torbay Hospital

    Torquay, England, TQ2 7AA

  • Warrington Hospital NHS Trust

    Warrington, England, WA5 1QG

  • Warwick Hospital

    Warwick, England, CV34 5BW

  • Sandwell General Hospital

    West Bromwich, England, B71 4HJ

  • Weston General Hospital

    Weston-super-Mare, England, BS23 4TQ

  • West Cumberland Hospital

    Whitehaven, England, CA28 8JG

  • New Cross Hospital

    Wolverhampton, England, WV10 0QP

  • Worthing Hospital

    Worthing, England, BN11 2DH

  • Yeovil District Hospital

    Yeovil, England, BA21 4AT

  • Cancer Care Centre at York Hospital

    York, England, Y031 8HE

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Being tested
ibandronate sodium
Keywords
stage IV prostate cancer, bone metastases, pain, recurrent prostate cancer
Medical subject headings
Neoplasm Metastasis, Pain, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ibandronate sodiumDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2004 (estimated)
  2. Study startApr 2003
  3. Study completionJul 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Masking
None (open label)
Enrolment
580 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00082927
Sponsor's protocol ID
CRUK-NCRI-RT-02-01
Other IDs
CDR0000361728, EU-20224, RIB, ISRCTN86185157
Status last verified
Jun 2009
First submitted
14 May 2004
Last updated
26 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ibandronate sodium in people with Metastatic Cancer and Pain, run by Cancer Research UK at 52 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00082927.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2013.

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