Completed

A Phase III International Randomized Trial Of Single Versus Multiple Fractions For Re-Irradiation Of Painful Bone Metastases

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What is being tested

radiation therapy

Radiation
Who is being recruted

Neoplasm Metastasis
+1

+ Neoplasms
+ Neoplastic Processes
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2004
See protocol details

Summary

Principal SponsorNCIC Clinical Trials Group
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: January 22, 2004Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Compare pain relief in patients undergoing single-fraction vs multiple-fraction re-irradiation of painful bone metastases at 2 months after treatment. Secondary * Compare overall pain relief in patients treated with these regimens. * Compare time to pain progression in patients treated with these regimens. * Assess relationship between response to initial radiation and pain relief after re-irradiation in these patients. * Compare changes in functional interference after re-irradiation using the Brief Pain Inventory in patients treated with these regimens. * Compare quality of life of patients treated with these regimens (patients in Canada, France, the Netherlands, and patients registered through RTOG). * Determine characteristics of non-responders (to both initial and re-irradiation) among patients treated with these regimens. * Monitor the incidence of acute severe radiation-related side effects in patients treated with these regimens. * Monitor the incidence of in-field pathological fractures and spinal cord compression in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to response to initial radiotherapy (yes vs no), initial fractionation (single fraction vs multiple fraction), and participating center. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive single-fraction radiotherapy (8Gy) on day 1. * Arm II: Patients receive multiple-fraction radiotherapy (to a total of 20Gy) over 5 days or over 8 days if re-irradiation of the spine and/or whole pelvis is involved AND prior initial radiotherapy was given in multiple fractions. At least 4 weeks after the first re-treatment, patients in both arms may receive a second re-treatment at the discretion of the treating oncologist. Patients complete a Brief Pain Inventory questionnaire at baseline, on days 7 and 14, monthly during months 1-6, and at months 9 and 12. Acute Toxicities are assessed on days 7 and 14. Quality of Life is assessed at baseline and then monthly during months 1-6 for patients from participating groups. Patients are followed for up to 1 year. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 850 patients will be accrued for this study.

Official TitleA Phase III International Randomized Trial Of Single Versus Multiple Fractions For Re-Irradiation Of Painful Bone Metastases 
NCT00797173NCT00080912
Principal SponsorNCIC Clinical Trials Group
Last updated: January 14, 2026
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
850 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

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 treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

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
Neoplasm Metastasis
Neoplasms
Neoplastic Processes
Pathologic Processes
Criteria

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed malignancy * Diagnosis by needle biopsy, bone marrow biopsy, cytology, or surgical biopsy or resection * Bone metastases at clinically painful areas confirmed by any of the following: * Plain radiographs * Radionuclide bone scans * CT scans * Magnetic resonance imaging * Worst pain score of ≥ 2/10 using the baseline Brief Pain Inventory * Pain arising from previously irradiated metastases and not from progressive disease in adjoining or remote areas * Initial radiotherapy field is reproducible for re-irradiation * Current treatment field for palliative radiotherapy must be the same size or smaller than the initial treatment field * No clinical or radiological evidence of pathological fractures in the target site extremities. * No radiological evidence of high-risk lesions for pathological fractures in the extremities (lytic lesions \> 3cm or \> 50% cortical erosion of bone diameter) if target site AND patient is a candidate for surgical intervention. * No clinical or radiological evidence of spinal cord compression at target site. PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 50-100% Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * Not pregnant or nursing * Fertile patients must use effective barrier contraception * Able and willing to complete quality of life questionnaire in English, French, Dutch, or Spanish (if randomized by Canadian, Dutch, French or RTOG centre) * Must be accessible for treatment follow-up * Informed consent PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * No more than 1 prior course of radiotherapy to the target site * No prior radiotherapy dose ≥ 24 Gy in 6 fractions, 27 Gy in 8 fractions, or 30 Gy in 10 fractions to the spine or any part of the pelvis encompassing small or large bowel and/or the rectum, if these sites are being treated on study * Initial doses of 24 Gy in 6 fractions, 27 Gy in 8 fractions or 30 Gy in 10 fractions to the acetabulum or hip and proximal femur allowed as long as the medial field border of the initial treatment did not cross midline * No prior radiotherapy dose \> 30Gy in 10 fractions to the ribs or extremities if these sites are being treated on study * More than 30 days since prior strontium chloride Sr 89 * More than 30 days since prior half-body radiotherapy, including the current re-irradiation field * At least 4 weeks since initial radiotherapy Surgery * No prior palliative surgery in treatment area * No concurrent surgical intervention on treatment area Other * No prior participation on this protocol * No plan to make an immediate change in analgesic regimen

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Patients receive single-fraction radiotherapy (8 Gy) on day 1.

Given in a single fraction or multiple fractions
Group II
Active Comparator
Patients receive multiple-fraction radiotherapy (to a total of 20 Gy) over 5 days or over 8 days if re-irradiation of the spine and/or whole pelvis is involved AND prior initial radiotherapy was given in multiple fractions.

Given in a single fraction or multiple fractions
Study Objectives
Primary Objectives

The primary endpoint of this study is Overall Response Rate (complete response and partial response) at two months after the first fraction of re-irradiation. A complete response was defined as a Brief Pain Inventory worst-pain score of zero with no associated increase in daily oral morphine equivalent. A partial response was defined as pain that persisted after treatment, either with a worst-pain score reduction of 2 or more and no increase in daily oral morphine equivalent consumption, or no increase in pain and a reduction in daily oral morphine equivalent consumption of at least 25%.

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 12 locations
Suspended
Tom Baker Cancer CentreCalgary, CanadaSee the location
Suspended
The Vitalite Health Network - Dr. Leon RichardMoncton, Canada
Suspended
Juravinski Cancer Centre at Hamilton Health SciencesHamilton, Canada
Suspended
Cancer Centre of Southeastern Ontario at KingstonKingston, Canada
Completed12 Study Centers
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