A multicentre randomised trial of single dose Radiotherapy compared to Ibandronate for localised metastatic Bone pain
| ISRCTN | ISRCTN86185157 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86185157 |
| ClinicalTrials.gov (NCT) | NCT00082927 |
| Protocol serial number | C2422/A3027 |
| Sponsor | Cancer Research UK (CRUK) (UK) |
| Funders | Cancer Research UK (CRUK( (UK), Roche (UK) - have committed to providing free ibandronate |
- Submission date
- 02/06/2003
- Registration date
- 02/06/2003
- Last edited
- 28/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Dr PJ Hoskin
Scientific
Scientific
Mount Vernon Hospital
Rickmansworth Road
Northwood
HA6 2RN
United Kingdom
| Phone | +44 (0)20 7679 8036 |
|---|---|
| rib@ctc.ucl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A multicentre randomised trial of single dose Radiotherapy compared to Ibandronate for localised metastatic Bone pain |
| Study acronym | RIB |
| Study objectives | 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(s) | MREC approved |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Ibandronate |
| Primary outcome measure(s) | 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. |
| Key secondary outcome measure(s) | 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. |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 580 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/04/2003 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Mount Vernon Hospital
Northwood
HA6 2RN
United Kingdom
HA6 2RN
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 04/08/2015 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
06/08/2009: The overall trial end date has changed from 31/08/2008 to 31/12/2009.
