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Single-Fraction Radiation Therapy Compared With Multiple-Fraction Reirradiation Therapy in Treating Patients With Painful Bone Metastases
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2009
First Received: April 7, 2004   Last Updated: November 25, 2009   History of Changes
Sponsor: NCIC Clinical Trials Group
Collaborators: National Cancer Institute (NCI)
Radiation Therapy Oncology Group
Trans Tasman Radiation Oncology Group at Calvary Mater Newcastle
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00080912
  Purpose

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

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


Condition Intervention Phase
Metastatic Cancer
Pain
 Radiation: radiation therapy
 Phase III

Study Type: Interventional
Study Design: Treatment, Randomized
Official Title: A Phase III International Randomized Trial Of Single Versus Multiple Fractions For Re-Irradiation Of Painful Bone Metastases

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Pain relief measured by the Brief Pain Inventory at 2 months after treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life assessed by the EORTC QLQ-C30 [ Designated as safety issue: No ]

Estimated Enrollment: 850
Study Start Date: January 2004
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm I: Experimental
Patients receive single-fraction radiotherapy on day 1.
Radiation: radiation therapy
Given in a single fraction or multiple fractions
Arm II: Active Comparator
Patients receive multiple-fraction radiotherapy once daily on days 1-5 or on days 1-8 if re-irradiation of the spine and/or whole pelvis is involved AND prior initial radiotherapy was given in multiple fractions.
Radiation: radiation therapy
Given in a single fraction or multiple fractions

Detailed Description:

OBJECTIVES:

Primary

  • Compare pain relief in patients undergoing single-fraction vs multiple-fraction re-irradiation of painful bone metastases.

Secondary

  • Compare overall pain relief in patients treated with these regimens.
  • Compare time to pain progression in patients treated with these regimens.
  • Correlate initial irradiation response with 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, 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 on day 1.
  • Arm II: Patients receive multiple-fraction radiotherapy once daily on days 1-5 or on days 1-8 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 in the absence of unacceptable pain progression or unacceptable toxicity.

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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 radiological evidence of high-risk lesions for pathological fractures in the extremities (lytic lesions > 3cm or > 50% cortical erosion of bone diameter) AND patient is a candidate for surgical intervention.
  • No clinical or radiological evidence of spinal cord compression

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
  • Must be accessible for treatment follow-up

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 prior 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00080912

  Hide Study Locations
Locations
United States, California
Alta Bates Summit Medical Center - Summit Campus Recruiting
Oakland, California, United States, 94609
Contact: Clinical Trials Office - Alta Bates Summit Medical Center - Su     510-204-1414        
Bay Area Breast Surgeons, Incorporated Recruiting
Oakland, California, United States, 94609
Contact: James H. Feusner, MD     510-428-3689        
CCOP - Bay Area Tumor Institute Recruiting
Oakland, California, United States, 94609
Contact: James H. Feusner, MD     510-428-3689        
Contra Costa Regional Medical Center Recruiting
Martinez, California, United States, 94553-3156
Contact: James H. Feusner, MD     510-428-3689        
Doctors Medical Center - San Pablo Campus Recruiting
San Pablo, California, United States, 94806
Contact: James H. Feusner, MD     510-428-3689        
East Bay Radiation Oncology Center Recruiting
Castro Valley, California, United States, 94546
Contact: James H. Feusner, MD     510-428-3689        
Eden Medical Center Recruiting
Castro Valley, California, United States, 94546
Contact: James H. Feusner, MD     510-428-3689        
El Camino Hospital Cancer Center Recruiting
Mountain View, California, United States, 94040
Contact: Clinical Trials Office - El Camino Hospital Cancer Center     650-988-7623        
Enloe Cancer Center at Enloe Medical Center Recruiting
Chico, California, United States, 95926
Contact: Clinical Trials Office - Enloe Cancer Center at Enloe Medical     530-332-3808        
Recruiting
Santa Clara, California, United States, 95051
Contact: Louis Fehrenbacher, MD     707-651-2577        
Highland General Hospital Recruiting
Oakland, California, United States, 94602
Contact: James H. Feusner, MD     510-428-3689        
Kaiser Foundation Hospital - San Rafael Recruiting
San Rafael, California, United States, 94903
Contact: Louis Fehrenbacher, MD     707-651-2577        
Kaiser Permanente - Deer Valley Recruiting
Antioch, California, United States, 94531
Contact: Louis Fehrenbacher, MD     707-651-2577        
Kaiser Permanente - Division of Research - Oakland Recruiting
Oakland, California, United States, 94611
Contact: Louis Fehrenbacher, MD     707-651-2577        
Kaiser Permanente - Fremont Recruiting
Fremont, California, United States, 94538
Contact: Louis Fehrenbacher, MD     707-651-2577        
Kaiser Permanente Medical Center - Hayward Recruiting
Hayward, California, United States, 94545
Contact: Louis Fehrenbacher, MD     707-651-2577        
Kaiser Permanente Medical Center - Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Michael R. Girvigian     323-667-4011        
Kaiser Permanente Medical Center - Oakland Recruiting
Oakland, California, United States, 94611
Contact: Louis Fehrenbacher, MD     707-651-2577        
Kaiser Permanente Medical Center - Rancho Cordova Recruiting
Rancho Cardova, California, United States, 95670
Contact: Louis Fehrenbacher, MD     707-651-2577        
Kaiser Permanente Medical Center - Redwood City Recruiting
Redwood City, California, United States, 94063
Contact: Louis Fehrenbacher, MD     707-651-2577        
Valley Care Medical Center Recruiting
Pleasanton, California, United States, 94588
Contact: James H. Feusner, MD     510-428-3689        
Kaiser Permanente Medical Center - Roseville Recruiting
Roseville, California, United States, 95661
Contact: Louis Fehrenbacher, MD     707-651-2577        
Kaiser Permanente Medical Center - Sacramento Recruiting
Sacramento, California, United States, 95825
Contact: Louis Fehrenbacher, MD     707-651-2577        
Kaiser Permanente Medical Center - San Francisco Geary Campus Recruiting
San Francisco, California, United States, 94115
Contact: Louis Fehrenbacher, MD     707-651-2577        
Kaiser Permanente Medical Center - Santa Clara Kiely Campus Recruiting
Santa Clara, California, United States, 95051
Contact: Louis Fehrenbacher, MD     707-651-2577        
Kaiser Permanente Medical Center - Santa Rosa Recruiting
Santa Rosa, California, United States, 95403
Contact: Louis Fehrenbacher, MD     707-651-2577        
Kaiser Permanente Medical Center - Santa Teresa Recruiting
San Jose, California, United States, 95119
Contact: Louis Fehrenbacher, MD     707-651-2577        
Kaiser Permanente Medical Center - South San Francisco Recruiting
South San Francisco, California, United States, 94080
Contact: Louis Fehrenbacher, MD     707-651-2577        
Kaiser Permanente Medical Center - Vacaville Recruiting
Vacaville, California, United States, 95688
Contact: Louis Fehrenbacher, MD     707-651-2577        
Kaiser Permanente Medical Center - Vallejo Recruiting
Vallejo, California, United States, 94589
Contact: Louis Fehrenbacher, MD     707-651-2577        
Kaiser Permanente Medical Center - Walnut Creek Recruiting
Walnut Creek, California, United States, 94596
Contact: Louis Fehrenbacher, MD     707-651-2577        
Kaiser Permanente Medical Facility - Stockton Recruiting
Stockton, California, United States, 95210
Contact: Louis Fehrenbacher, MD     707-651-2577        
Larry G Strieff MD Medical Corporation Recruiting
Oakland, California, United States, 94609
Contact: James H. Feusner, MD     510-428-3689        
Providence Saint Joseph Medical Center - Burbank Recruiting
Burbank, California, United States, 91505
Contact: Clinical Trials Office - Providence Saint Joseph Medical Cente     818-847-3220        
Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center Recruiting
Pomona, California, United States, 91767
Contact: Clinical Trials Office - Robert and Beverly Lewis Family Cance     909-865-9555        
Rohnert Park Cancer Center Recruiting
Rohnert Park, California, United States, 94928
Contact: Louis Fehrenbacher, MD     707-651-2577        
South Sacramento Cancer Center Recruiting
Sacramento, California, United States, 95823
Contact: Louis Fehrenbacher, MD     707-651-2577        
South Sacramento Kaiser-Permanente Medical Center Recruiting
Sacramento, California, United States, 95823
Contact: Louis Fehrenbacher, MD     707-651-2577        
Tom K Lee, Incorporated Recruiting
Oakland, California, United States, 94609
Contact: James H. Feusner, MD     510-428-3689        
Kaiser Permanente Medical Center - Richmond Recruiting
Richmond, California, United States, 94801
Contact: Louis Fehrenbacher, MD     707-651-2577        
Valley Medical Oncology Consultants - Castro Valley Recruiting
Castro Valley, California, United States, 94546
Contact: James H. Feusner, MD     510-428-3689        
Valley Medical Oncology Consultants - Pleasanton Recruiting
Pleasanton, California, United States, 94588
Contact: James H. Feusner, MD     510-428-3689        
Valley Medical Oncology Recruiting
Fremont, California, United States, 94538
Contact: James H. Feusner, MD     510-428-3689        
United States, Colorado
Penrose Cancer Center at Penrose Hospital Recruiting
Colorado Springs, Colorado, United States, 80933
Contact: Clinical Trials Office - Penrose Cancer Center     719-776-5275        
Poudre Valley Radiation Oncology Recruiting
Fort Collins, Colorado, United States, 80528
Contact: C. Kelley Simpson, MD     970-482-3328        
St. Mary - Corwin Regional Medical Center Recruiting
Pueblo, Colorado, United States, 81004
Contact: John D. Stageberg     719-557-4000        
University of Colorado Cancer Center at UC Health Sciences Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Clinical Trials Office - University of Colorado Cancer Center     720-848-0650        
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center - Miami Recruiting
Miami, Florida, United States, 33136
Contact: University of Miami Sylvester Comprehensive Cancer Center Clin     866-574-5124     Sylvester@emergingmed.com    
United States, Georgia
Emory Crawford Long Hospital Recruiting
Atlanta, Georgia, United States, 30308
Contact: Scott Edelman     404-686-4411        
Georgia Cancer Center for Excellence at Grady Memorial Hospital Recruiting
Atlanta, Georgia, United States, 30303
Contact: Scott Edelman     404-489-9000        
Northeast Georgia Medical Center Recruiting
Gainesville, Georgia, United States, 30501
Contact: Frank G. Lake, MD     770-535-3393        
Veterans Affairs Medical Center - Atlanta (Decatur) Recruiting
Decatur, Georgia, United States, 30033
Contact: Scott Edelman     404-728-7680        
Winship Cancer Institute of Emory University Recruiting
Altanta, Georgia, United States, 30322
Contact: Scott Edelman     404-778-5180        
United States, Illinois
Advocate Lutheran General Cancer Care Center Recruiting
Park Ridge, Illinois, United States, 60068-1174
Contact: Clinical Trials Office - Advocate Lutheran General Cancer Care     847-384-3621        
Alexian Brothers Radiation Oncology Recruiting
Elk Grove Village, Illinois, United States, 60007
Contact: Martin J. Boyer, MD     847-981-5760        
Creticos Cancer Center at Advocate Illinois Masonic Medical Center Recruiting
Chicago, Illinois, United States, 60657
Contact: Clinical Trials Office - Creticos Cancer Center at Advocate Il     773-296-5360        
Good Samaritan Cancer Care Center at Advocate Good Samaritan Hospital Recruiting
Downers Grove, Illinois, United States, 60515-1500
Contact: Clinical Trials Office - Good Samaritan Cancer Care Center at     630-275-1270        
Good Shepherd Hospital Recruiting
Barrington, Illinois, United States, 60010
Contact: John H. Chang, MD     847-723-8030        
John H. Stroger, Jr. Hospital of Cook County Recruiting
Chicago, Illinois, United States, 60612-3785
Contact: Nathanial O. Holloway     312-864-3200        
Methodist Medical Center of Illinois Recruiting
Peoria, Illinois, United States, 61636
Contact: Clinical Trials Office - Methodist Medical Center of Illinois     309-243-3000        
United States, Indiana
CCOP - Northern Indiana CR Consortium Recruiting
South Bend, Indiana, United States, 46601
Contact: David A. Hornback, MD     574-647-7461        
Center for Cancer Therapy at LaPorte Hospital and Health Services Recruiting
La Porte, Indiana, United States, 46350
Contact: David A. Hornback, MD     574-647-7461        
Elkhart General Hospital Recruiting
Elkhart, Indiana, United States, 46515
Contact: David A. Hornback, MD     574-647-7461        
Howard Community Hospital Recruiting
Kokomo, Indiana, United States, 46904
Contact: David A. Hornback, MD     574-647-7461        
Indiana University Melvin and Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202-5289
Contact: Clinical Trials Office - Indiana University Cancer Center     317-274-2552        
Memorial Hospital of South Bend Recruiting
South Bend, Indiana, United States, 46601
Contact: Clinical Trials Office - Memorial Hospital of South Bend     800-284-7370        
South Bend Clinic Recruiting
South Bend, Indiana, United States, 46617
Contact: David A. Hornback, MD     574-647-7461        
Radiation Oncology Associates Southwest Recruiting
Fort Wayne, Indiana, United States, 46804
Contact: Tony T. Lee     260-373-7850        
Saint John's Cancer Center at Saint John's Medical Center Recruiting
Anderson, Indiana, United States, 46016
Contact: Darrel L. Ross     765-646-8459        
Saint Joseph Regional Medical Center Recruiting
South Bend, Indiana, United States, 46617
Contact: David A. Hornback, MD     574-647-7461        
Parkview Regional Cancer Center at Parkview Health Recruiting
Fort Wayne, Indiana, United States, 46805
Contact: Brian K. Chang     260-373-7850        
Veterans Affairs Medical Center - Indianapolis Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Achilles J. Fakiris     317-554-0000        
United States, Kansas
Menorah Medical Center Recruiting
Overland Park, Kansas, United States, 66209
Contact: Rakesh Gaur, MD     816-823-0555        
Saint Luke's Hospital - South Recruiting
Overland Park, Kansas, United States, 66213
Contact: Rakesh Gaur, MD     816-823-0555        
Shawnee Mission Medical Center Recruiting
Shawnee Mission, Kansas, United States, 66204
Contact: Rakesh Gaur, MD     816-823-0555        
United States, Kentucky
James Graham Brown Cancer Center at University of Louisville Recruiting
Louisville, Kentucky, United States, 40292
Contact: William J. Spanos, Jr.     502-562-4158        
Lucille P. Markey Cancer Center at University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536-0093
Contact: Clinical Trials Office - Markey Cancer Center at University of     859-257-3379        
United States, Massachusetts
Boston University Cancer Research Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Clinical Trials Office - Boston University Cancer Research Cen     617-353-7571        
United States, Michigan
Borgess Medical Center Recruiting
Kalamazoo, Michigan, United States, 49001
Contact: Raymond S. Lord, MD     269-373-7458        
Bronson Methodist Hospital Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Raymond S. Lord, MD     269-373-7458        
Community Cancer Center of Monroe Recruiting
Monroe, Michigan, United States, 48162
Contact: Paul L. Schaefer, MD     419-479-5605        
Haematology-Oncology Associates of Ohio and Michigan, PC Recruiting
Lambertville, Michigan, United States, 48144
Contact: Paul L. Schaefer, MD     419-479-5605        
Hickman Cancer Center at Bixby Medical Center Recruiting
Adrian, Michigan, United States, 49221
Contact: Clinical Trials Office - Hickman Cancer Center at Bixby Medica     517-265-0116        
Lakeland Regional Cancer Care Center - St. Joseph Recruiting
St. Joseph, Michigan, United States, 49085
Contact: David A. Hornback, MD     574-647-7461        
Mercy Memorial Hospital - Monroe Recruiting
Monroe, Michigan, United States, 48162
Contact: Paul L. Schaefer, MD     419-479-5605        
University of Michigan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109-0942
Contact: Clinical Trials Office - University of Michigan Comprehensive     800-865-1125        
West Michigan Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49007-3731
Contact: Clinical Trials Office - West Michigan Cancer Center     269-373-7458        
United States, Minnesota
CentraCare Clinic - River Campus Recruiting
Saint Cloud, Minnesota, United States, 56303
Contact: Barbi L. Kaplan-Frenkel, DO     320-229-4901        
Coborn Cancer Center Recruiting
Saint Cloud, Minnesota, United States, 56303
Contact: Barbi L. Kaplan-Frenkel, DO     320-229-4901        
United States, Missouri
CCOP - Kansas City Recruiting
Kansas City, Missouri, United States, 64131
Contact: Rakesh Gaur, MD     816-823-0555        
Heartland Regional Medical Center Recruiting
Saint Joseph, Missouri, United States, 64506
Contact: Rakesh Gaur, MD     816-823-0555        
Liberty Hospital Recruiting
Liberty, Missouri, United States, 64068
Contact: Rakesh Gaur, MD     816-823-0555        
North Kansas City Hospital Recruiting
Kansas City, Missouri, United States, 64116
Contact: Rakesh Gaur, MD     816-823-0555        
Parvin Radiation Oncology Recruiting
Kansas City, Missouri, United States, 64116
Contact: Rakesh Gaur, MD     816-823-0555        
Research Medical Center Recruiting
Kansas City, Missouri, United States, 64132
Contact: Rakesh Gaur, MD     816-823-0555        
Saint Luke's Cancer Institute at Saint Luke's Hospital Recruiting
Kansas City, Missouri, United States, 64111
Contact: Rakesh Gaur, MD     816-823-0555        
Saint Luke's East - Lee's Summit Recruiting
Lee's Summit, Missouri, United States, 64086
Contact: Rakesh Gaur, MD     816-823-0555        
St. Joseph Medical Center Recruiting
Kansas City, Missouri, United States, 64114
Contact: Rakesh Gaur, MD     816-823-0555        
Truman Medical Center - Hospital Hill Recruiting
Kansas City, Missouri, United States, 64108
Contact: Rakesh Gaur, MD     816-823-0555        
United States, Nebraska
Good Samaritan Cancer Center at Good Samaritan Hospital Recruiting
Kearney, Nebraska, United States, 68848-1990
Contact: Clinical Trials Office - Good Samaritan Cancer Center at Good     308-865-7963        
Methodist Estabrook Cancer Center Recruiting
Omaha, Nebraska, United States, 68114
Contact: Tien-Shew W. Huang     402-354-5890        
United States, New Hampshire
Kingsbury Center for Cancer Care at Cheshire Medical Center Recruiting
Keene, New Hampshire, United States, 03431
Contact: Alan C. Hartford, MD, PhD     603-650-6600        
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756-0002
Contact: Clinical Trials Office - Norris Cotton Cancer Center     603-650-7609     cancerhelp@dartmouth.edu    
United States, New Jersey
Cancer Institute of New Jersey at Cooper University Hospital - Camden Recruiting
Camden, New Jersey, United States, 08103
Contact: Clinical Trial Office - Cancer Institute of New Jersey at Coop     856-325-6757        
Cancer Institute of New Jersey at Cooper - Voorhees Recruiting
Voorhees, New Jersey, United States, 08043
Contact: Clinical Trials Office - Cancer Institute of New Jersey at Coo     856-325-6757        
United States, New York
CCOP - Hematology-Oncology Associates of Central New York Recruiting
East Syracuse, New York, United States, 13057
Contact: Jeffrey J. Kirshner, MD     315-472-7504        
Veterans Affairs Medical Center - Brooklyn Recruiting
Brooklyn, New York, United States, 11209
Contact: Contact Person     718-630-3574        
United States, North Carolina
Rutherford Hospital Recruiting
Rutherfordton, North Carolina, United States, 28139
Contact: James D. Bearden, MD     864-560-6812        
Wayne Memorial Hospital, Incorporated Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: James N. Atkins, MD     919-580-0000        
Wayne Radiation Oncology Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: James N. Atkins, MD     919-580-0000        
United States, Ohio
Barberton Citizens Hospital Recruiting
Barberton, Ohio, United States, 44203
Contact: William F. Demas, MD     330-375-3557        
Cancer Care Center, Incorporated Recruiting
Salem, Ohio, United States, 44460
Contact: William F. Demas, MD     330-375-3557        
Hematology Oncology Center Recruiting
Elyria, Ohio, United States, 44035
Contact: Paul L. Schaefer, MD     419-479-5605        
CCOP - Toledo Community Hospital Recruiting
Toledo, Ohio, United States, 43617
Contact: Paul L. Schaefer, MD     419-479-5605        
Cleveland Clinic - Wooster Recruiting
Wooster, Ohio, United States, 44691
Contact: Clinical Trials Office - Cleveland Clinic - Wooster     800-862-7798        
Cleveland Clinic Cancer Center at Fairview Hospital Recruiting
Cleveland, Ohio, United States, 44111
Contact: Clinical Trials Office - Cleveland Clinic Cancer Center at Fai     216-476-9362        
Cleveland Clinic Cancer Center Recruiting
Independence, Ohio, United States, 44131
Contact: John H. Suh, MD     216-444-5574        
Cleveland Clinic Taussig Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente     866-223-8100        
David L. Rike Cancer Center at Miami Valley Hospital Recruiting
Dayton, Ohio, United States, 45409
Contact: Clinical Trials Office - David L. Rike Cancer Center at Miami     937-208-2079        
Flower Hospital Cancer Center Recruiting
Sylvania, Ohio, United States, 43560
Contact: Clinical Trials Office - Flower Hospital Cancer Center     419-824-1842        
Fulton County Health Center Recruiting
Wauseon, Ohio, United States, 43567
Contact: Clinical Trials Office - Fulton County Health Center     419-330-2708        
Cancer Treatment Center Recruiting
Wooster, Ohio, United States, 44691
Contact: Clinical Trials Office - Cancer Treatment Center     330-375-4221        
Hillcrest Cancer Center at Hillcrest Hospital Recruiting
Mayfield Heights, Ohio, United States, 44124
Contact: John H. Suh, MD     216-444-5574        
Lima Memorial Hospital Recruiting
Lima, Ohio, United States, 45804
Contact: Paul L. Schaefer, MD     419-479-5605        
Medical University of Ohio Cancer Center Recruiting
Toledo, Ohio, United States, 43614
Contact: Clinical Trials Office - Medical University of Ohio Cancer Cen     419-383-6583        
Mercy Hospital of Tiffin Recruiting
Tiffin, Ohio, United States, 44883
Contact: Paul L. Schaefer, MD     419-479-5605        
North Coast Cancer Care - Clyde Recruiting
Clyde, Ohio, United States, 43410
Contact: Paul L. Schaefer, MD     419-479-5605        
St. Luke's Hospital Recruiting
Maumee, Ohio, United States, 43537
Contact: Paul L. Schaefer, MD     419-479-5605        
Northwest Ohio Oncology Center Recruiting
Maumee, Ohio, United States, 43537-1839
Contact: Paul L. Schaefer, MD     419-479-5605        
St. Anne Mercy Hospital Recruiting
Toledo, Ohio, United States, 43623
Contact: Paul L. Schaefer, MD     419-479-5605        
St. Charles Mercy Hospital Recruiting
Oregon, Ohio, United States, 43616
Contact: Paul L. Schaefer, MD     419-479-5605        
North Coast Cancer Care, Incorporated Recruiting
Sandusky, Ohio, United States, 44870
Contact: Paul L. Schaefer, MD     419-479-5605        
St. Vincent Mercy Medical Center Recruiting
Toledo, Ohio, United States, 43608
Contact: Paul L. Schaefer, MD     419-479-5605        
Summa Center for Cancer Care at Akron City Hospital Recruiting
Akron, Ohio, United States, 44309-2090
Contact: Clinical Trials Office - Akron City Hospital     330-375-6101        
Toledo Clinic - Oregon Recruiting
Oregon, Ohio, United States, 43616
Contact: Paul L. Schaefer, MD     419-479-5605        
Toledo Clinic, Incorporated - Main Clinic Recruiting
Toledo, Ohio, United States, 43623
Contact: Paul L. Schaefer, MD     419-479-5605        
Toledo Hospital Recruiting
Toledo, Ohio, United States, 43606
Contact: Clinical Trials Office - Toledo Hospital     419-824-1842        
Wood County Oncology Center Recruiting
Bowling Green, Ohio, United States, 43402
Contact: Paul L. Schaefer, MD     419-479-5605        
United States, Pennsylvania
Rosenfeld Cancer Center at Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Contact: Clinical Trials Office - Rosenfeld Cancer Center at Abington M     215-481-2402        
United States, South Carolina
AnMed Cancer Center Recruiting
Anderson, South Carolina, United States, 29621
Contact: Clinical Trials Office - AnMed Cancer Center     864-512-1000        
CCOP - Upstate Carolina Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: Clinical Trials Office - CCOP - Upstate Carolina     800-486-5941        
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: Clinical Trials Office - Gibbs Regional Cancer Center     800-486-5941        
United States, Vermont
Community Cancer Center at Rutland Regional Medical Center Recruiting
Rutland, Vermont, United States, 05701
Contact: Richard D. Lovett, MD     802-747-1831        
Norris Cotton Cancer Center - North Recruiting
Saint Johnsbury, Vermont, United States, 05819
Contact: Alan C. Hartford, MD, PhD     603-650-6600        
United States, Virginia
Fredericksburg Oncology, Incorporated Recruiting
Fredericksburg, Virginia, United States, 22401
Contact: Paul L. Schaefer, MD     419-479-5605        
United States, Wisconsin
Gundersen Lutheran Center for Cancer and Blood Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Clinical Trials Office - Gundersen Lutheran Cancer Center     608-775-2385     cancerctr@gundluth.org    
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Clinical Trials Office - Vince Lombardi Cancer Clinic     414-649-5717        
West Allis Memorial Hospital Recruiting
West Allis, Wisconsin, United States, 53227
Contact: Clinical Trials Office - West Allis Memorial Hospital     414-649-5717        
Canada, Alberta
Tom Baker Cancer Centre - Calgary Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Marc Kerba     403-521-3164        
Canada, New Brunswick
Doctor Leon Richard Oncology Centre Recruiting
Moncton, New Brunswick, Canada, E1C 8X3
Contact: Fernando Rojas     506-862-4030        
Canada, Newfoundland and Labrador
Doctor H. Bliss Murphy Cancer Centre Recruiting
St. John's, Newfoundland and Labrador, Canada, AIB 3V6
Contact: Jonathan Greenland     709-777-7802        
Canada, Ontario
Cancer Care Program at Thunder Bay Regional Health Sciences Recruiting
Thunder Bay, Ontario, Canada, P7B 6V4
Contact: Margaret L. Anthes     807-684-7211        
Cancer Centre of Southeastern Ontario at Kingston General Hospital Recruiting
Kingston, Ontario, Canada, K7L 5P9
Contact: Catherine de Metz     613-549-6666        
Edmond Odette Cancer Centre at Sunnybrook Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Edward L.W. Chow     416-480-4998        
Grand River Regional Cancer Centre at Grand River Hospital Recruiting
Kitchener, Ontario, Canada, N2G 1G3
Contact: Dilip Panjwani     519-749-4300        
Margaret and Charles Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: William G. McMillan     905-387-9495        
Ottawa Hospital Regional Cancer Centre - General Campus Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Peter Cross     613-737-7700        
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Andrea Bezjak     416-946-2132        
Windsor Regional Cancer Centre at Windsor Regional Hospital Recruiting
Windsor, Ontario, Canada, N8W 2X3
Contact: Khalid J. Hirmiz     519-253-5253        
Canada, Quebec
CHUS-Hopital Fleurimont Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Abdenour Nabid     819-346-1110        
Hopital Notre-Dame du CHUM Recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Isabelle Roy     514-890-5420        
McGill Cancer Centre at McGill University Recruiting
Montreal, Quebec, Canada, H2W 1S6
Contact: Marc David     514-934-8040        
Sponsors and Collaborators
NCIC Clinical Trials Group
National Cancer Institute (NCI)
Radiation Therapy Oncology Group
Trans Tasman Radiation Oncology Group at Calvary Mater Newcastle
Investigators
Study Chair: Edward L.W. Chow, MD Edmond Odette Cancer Centre at Sunnybrook
Study Chair: William F. Hartsell, MD Alexian Brothers Radiation Oncology
Study Chair: Daniel Roos, MD Royal Adelaide Hospital Cancer Centre
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

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. Review. No abstract available.

Responsible Party: NCIC-Clinical Trials Group ( Regulatory Affairs Associate )
Study ID Numbers: CDR0000357423, CAN-NCIC-SC20, RTOG-0433, TROG-03.08
Study First Received: April 7, 2004
Last Updated: November 25, 2009
ClinicalTrials.gov Identifier: NCT00080912     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
bone metastases
pain

Additional relevant MeSH terms:
Neoplasms
Neoplastic Processes
Pathologic Processes
Neoplasm Metastasis

ClinicalTrials.gov processed this record on November 27, 2009



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