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Metastatic CancerNCT00080912

Single vs Multiple-Fraction Therapy in Treating Patients With Previously Irradiated Painful Bone Metastases

A study testing radiation therapy in people with Metastatic Cancer and Pain, run by NCIC Clinical Trials Group at 12 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether single-fraction (single-dose) re-irradiation therapy is as effective as multiple-fraction (many small doses of radiation therapy) re-irradiation therapy in relieving bone pain caused by bone metastases. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Cancer, Pain
What is being tested?
radiation therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
850 participants
Where
12 sitesCanada
Study dates
22 Jan 2004to 16 Jan 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Canada12 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • Cancer Centre of Southeastern Ontario at Kingston

    Kingston, Ontario, K7L 5P9

  • Grand River Regional Cancer Centre

    Kitchener, Ontario, N2G 1G3

  • The Vitalite Health Network - Dr. Leon Richard

    Moncton, New Brunswick, E1C 8X3

  • CHUM - Hopital Notre-Dame

    Montreal, Quebec, H2L 4M1

  • McGill University - Dept. Oncology

    Montreal, Quebec, H2W 1S6

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Centre hospitalier universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4

  • Thunder Bay Regional Health Science Centre

    Thunder Bay, Ontario, P7B 6V4

  • Odette Cancer Centre

    Toronto, Ontario, M4N 3M5

  • Univ. Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

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

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether single-fraction (single-dose) re-irradiation therapy is as effective as multiple-fraction (many small doses of radiation therapy) re-irradiation therapy in relieving bone pain caused by bone metastases.

PURPOSE: This randomized phase III trial is studying single-dose radiation therapy to see if it works as well as multiple-dose radiation therapy in treating patients previously irradiated with painful bone metastases.

Read the detailed description

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.

Being tested
radiation therapy
Keywords
bone metastases, pain
Medical subject headings
Neoplasm Metastasis, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • radiation therapyRadiation

    Given in a single fraction or multiple fractions

Study groups in NCT00080912
Study groupRoleWhat they receive
Arm IExperimentalPatients receive single-fraction radiotherapy (8 Gy) on day 1.
Receives: Radiation: radiation therapy
Arm IIActive comparatorPatients 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.
Receives: Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Relief Measured by the Brief Pain Inventory at 2 Months After Treatment

    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%.

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2004 (estimated)
  2. Study start22 Jan 2004
  3. Primary completion10 Apr 2013
  4. Study completion16 Jan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
850 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00080912
Sponsor's protocol ID
SC20
Other IDs
CAN-NCIC-SC20, RTOG-0433, TROG-03.08, CDR0000357423
Status last verified
Apr 2020
First submitted
7 Apr 2004
Last updated
21 Aug 2023
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chow E, Hoskin PJ, Wu J, Roos D, van der Linden Y, Hartsell W, Vieth R, Wilson C, Pater J. A phase III international randomised trial comparing single with multiple fractions for re-irradiation of painful bone metastases: National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) SC 20. Clin Oncol (R Coll Radiol). 2006 Mar;18(2):125-8. doi: 10.1016/j.clon.2005.11.014. No abstract available.

    PubMed 16523812

  • Chow E, van der Linden YM, Roos D, Hartsell WF, Hoskin P, Wu JS, Brundage MD, Nabid A, Tissing-Tan CJ, Oei B, Babington S, Demas WF, Wilson CF, Meyer RM, Chen BE, Wong RK. Single versus multiple fractions of repeat radiation for painful bone metastases: a randomised, controlled, non-inferiority trial. Lancet Oncol. 2014 Feb;15(2):164-71. doi: 10.1016/S1470-2045(13)70556-4. Epub 2013 Dec 23.

    PubMed 24369114

  • Chow R, Ding K, Ganesh V, Meyer RM, van der Linden YM, Roos D, Hartsell WF, Hoskin P, Wu JSY, Nabid A, van Acht M, Wanders R, Babington S, Demas WF, Wilson CF, Wong RKS, Brundage M, Zhu L, Chow E. Gender and age make no difference in the re-irradiation of painful bone metastases: A secondary analysis of the NCIC CTG SC.20 randomized trial. Radiother Oncol. 2018 Mar;126(3):541-546. doi: 10.1016/j.radonc.2017.10.006. Epub 2017 Nov 5.

    PubMed 29102263

  • Chow E, Meyer RM, Chen BE, van der Linden YM, Roos D, Hartsell WF, Hoskin P, Wu JS, Nabid A, Tissing-Tan CJ, Oei B, Babington S, Demas WF, Wilson CF, Wong RK, Brundage M. Impact of reirradiation of painful osseous metastases on quality of life and function: a secondary analysis of the NCIC CTG SC.20 randomized trial. J Clin Oncol. 2014 Dec 1;32(34):3867-73. doi: 10.1200/JCO.2014.57.6264. Epub 2014 Oct 27.

    PubMed 25349296

Questions about this trial

What is this clinical trial studying?

A study testing radiation therapy in people with Metastatic Cancer and Pain, run by NCIC Clinical Trials Group at 12 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Relief Measured by the Brief Pain Inventory at 2 Months After Treatment (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00080912, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.

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