Completed

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

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What is being tested

ibandronate sodium

Drug
Who is being recruted

Metastatic Cancer

+ Pain
+ Prostate Cancer
Over 18 Years
How is the trial designed

Supportive Care Study

Phase 3
Interventional
Study Start: April 2003

Summary

Principal SponsorCancer Research UK
Last updated: June 26, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2003Actual date on which the first participant was enrolled.

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. 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.

Official TitleA Multicentre Randomised Trial Of Single Dose Radiotherapy Compared To Ibandronate For Localised Metastatic Bone Pain 
Principal SponsorCancer Research UK
Last updated: June 26, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
580 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Metastatic Cancer
Pain
Prostate Cancer
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



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 52 locations
Suspended
William Harvey HospitalAshford-Kent, United KingdomSee the location
Suspended
North Devon District HospitalBarnstaple, United Kingdom
Suspended
Basingstoke and North Hampshire NHS Foundation TrustBasingstoke, United Kingdom
Suspended
Royal United HospitalBath, United Kingdom

Completed52 Study Centers