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 number	NCT00082927
Secondary identifying numbers	C2422/A3027

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

http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-at-radiotherapy-or-ibandronate-for-pain-caused-by-prostate-cancer-that-has-spread-to-the-bone

Contact information

Dr PJ Hoskin
Scientific

Mount Vernon Hospital
Rickmansworth Road
Northwood
HA6 2RN
United Kingdom

Phone	+44 (0)20 7679 8036
Email	rib@ctc.ucl.ac.uk

Study information

Study design	Multicentre randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	Ibandronate
Primary outcome measure	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 study start date	01/04/2003
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	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

England
United Kingdom

Study participating centre

Mount Vernon Hospital

Northwood
HA6 2RN
United Kingdom

Sponsor information

Cancer Research UK (CRUK) (UK)
Charity

P.O. Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom

Phone	+44 (0)20 7317 5186
Email	kate.law@cancer.org.uk
Website	http://www.cancerresearch.org.uk
"ROR"	https://ror.org/054225q67

Funders

Funder type

Industry

Cancer Research UK (CRUK( (UK)
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

Roche (UK) - have committed to providing free ibandronate

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
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

Editorial Notes

06/08/2009: The overall trial end date has changed from 31/08/2008 to 31/12/2009.