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

NCT00080912 | Completed Results DMC

• 5 other identifiers: SC20CAN-NCIC-SC20RTOG-0433TROG-03.08CDR0000357423
• Study Type: interventional
• Target: 850
• Locations: 1 country
• Sites: 12

Brief 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. 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.

Conditions

Metastatic Cancer; Pain

Keywords

bone metastases; pain

Outcome Measures

Primary Outcomes (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%.

  2 months

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive single-fraction radiotherapy (8 Gy) on day 1.

Radiation: radiation therapy

Arm 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.

Radiation: radiation therapy

Interventions

radiation therapy RADIATION

Given in a single fraction or multiple fractions

Arm I; Arm II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead
• National Cancer Institute (NCI): collaborator
• Radiation Therapy Oncology Group: collaborator
• Trans Tasman Radiation Oncology Group: collaborator
• Cancer Research UK: collaborator
• Assistance Publique - Hôpitaux de Paris: collaborator

Study Sites (12)

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

The Vitalite Health Network - Dr. Leon Richard

Moncton, New Brunswick, E1C 8X3, Canada

Location

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

Cancer Centre of Southeastern Ontario at Kingston

Kingston, Ontario, K7L 5P9, Canada

Location

Grand River Regional Cancer Centre

Kitchener, Ontario, N2G 1G3, Canada

Location

Thunder Bay Regional Health Science Centre

Thunder Bay, Ontario, P7B 6V4, Canada

Location

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Univ. Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

CHUM - Hopital Notre-Dame

Montreal, Quebec, H2L 4M1, Canada

Location

McGill University - Dept. Oncology

Montreal, Quebec, H2W 1S6, Canada

Location

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Related Publications (4)

• 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.

  PMID: 16523812 BACKGROUND

• 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.

  PMID: 24369114 RESULT

• 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.

  PMID: 29102263 DERIVED

• 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.

  PMID: 25349296 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis; Pain

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Dr. Bingshu Chen
• Organization: NCIC Clinical Trials Group

bechen@ctg.queensu.ca

613-533-6000

Study Officials

• Edward LW Chow, MD

  Toronto Sunnybrook Regional Cancer Centre

  STUDY CHAIR

• William F. Hartsell, MD

  Advocate Good Samaratin Cancer Centre

  STUDY CHAIR

• Daniel Roos, MD

  Royal Adelaide Hospital Cancer Centre

  STUDY CHAIR

• Yvette von der Linden

  Radiotherapeutic Institution Friesland

  STUDY CHAIR

• Peter Hoskin

  Mount Vernon Cancer Centre

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2004
• First Posted: April 8, 2004
• Study Start: January 22, 2004
• Primary Completion: April 10, 2013
• Study Completion: January 16, 2014
• Last Updated: August 21, 2023
• Results First Posted: February 26, 2015

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (12)