Condition category
Cancer
Date applied
02/06/2003
Date assigned
02/06/2003
Last edited
15/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr PJ Hoskin

ORCID ID

Contact details

Mount Vernon Hospital
Rickmansworth Road
Northwood
HA6 2RN
United Kingdom
+44 (0)20 7679 8036
rib@ctc.ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00082927

Protocol/serial number

C2422/A3027

Study information

Scientific title

A multicentre randomised trial of single dose Radiotherapy compared to Ibandronate for localised metastatic Bone pain

Acronym

RIB

Study hypothesis

The current standard treatment for localised metastatic bone pain in the United Kingdom is single dose RadioTherapy (RT). There is also increasing evidence for, and use of, the bisphosphonate class of drugs in this setting. Their activity in bone pain from primary tumours of breast, lung and prostate has been shown in both single arm phase II studies and randomised double blind placebo controlled trials. No direct comparison between any bisphosphonate and RT has been undertaken.

The objective of this trial is to determine whether ibandronate given as a single intravenous infusion of 6 mg can give comparable rates of pain control as a single 8 Gy dose of local RT. 580 eligible patients with localised metastatic bone pain will be randomised to receive either treatment. Patients failing to achieve pain response at four weeks after initial treatment will be offered the alternate treatment arm.

Ethics approval

MREC approved

Study design

Multicentre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Localised metastatic bone pain

Intervention

There are two trial groups:
Group 1 will be given a single dose of radiotherapy.
Group 2 will be given a single dose of Ibandronate intravenously over one to two hours.

There will be systematic patient reported measurements of pain (which will be measured using a patient-completed pain assessment questionnaire based on the Wisconsin Brief Pain Inventory and adapted by the Radiation Therapy Oncology Group [RTOG] for bone pain), and quality of life (which will be measured using the Functional Assessment of Chronic Illness Therapy [FACIT] scale).

Intervention type

Drug

Phase

Phase III

Drug names

Ibandronate

Primary outcome measures

Pain response at 4 and 12 weeks post treatment. Formal definition of response includes pain score and analgesic use to achieve complete or partial response.

Secondary outcome measures

Quality of life and bone morbidity events including retreatment for bone pain, pathological fracture and spinal cord compression.

In addition, osteoclast activity will be measured using the urinary markers pyridinoline and deoxypyridinoline, and the relation of changing levels after treatment with response will be explored.

Overall trial start date

01/04/2003

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically or cytologically proven underlying primary malignancy of breast, lung or prostate, or sclerotic bone metastases in a patient presenting with a serum Prostate Specific Antigen (PSA) more than 100ng/ml
2. Bone metastases confirmed radiologically on plain x-ray, isotope scan, Computed Tomography (CT) or Magnetic Resonance (MR) scan
3. Single localised metastatic bone pain receiving optimal analgesics and adjuvant drugs including Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) unless contraindicated.
4. Clinical diagnosis of metastatic bone pain for which radiotherapy is indicated
5. Aged over 18 yrs with no upper age limit
6. Able to comply with pain chart and quality of life assessments
7. Able to give written informed consent.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

580

Participant exclusion criteria

1. Predicted life expectancy less than three months
2. Bisphosphonate treatment within the last six months
3. Any previous treatment that contraindicated radiotherapy or ibandronate or that would interfere with the action of either
4. Unfit to receive radiotherapy and ibandronate
5. Aspirin sensitive asthma in past medical history
6. Pregnancy and lactation

Recruitment start date

01/04/2003

Recruitment end date

31/12/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Mount Vernon Hospital
Northwood
HA6 2RN
United Kingdom

Sponsor information

Organisation

Cancer Research UK (CRUK) (UK)

Sponsor details

P.O. Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)20 7317 5186
kate.law@cancer.org.uk

Sponsor type

Charity

Website

http://www.cancerresearch.org.uk

Funders

Funder type

Industry

Funder name

Cancer Research UK (CRUK( (UK)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Roche (UK) - have committed to providing free ibandronate

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26242893

Publication citations

Additional files

Editorial Notes

Please note that as of 06/08/2009 the overall trial end date has changed from 31/08/2008 to 31/12/2009.