Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Related Publications
Trial Contact Information
Registry Information

Alternate Title

Single-Fraction Radiation Therapy Compared With Multiple-Fraction Reirradiation Therapy in Treating Patients With Painful Bone Metastases

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Active 18 and over NCI, Other CAN-NCIC-SC20 NCT00080912, RTOG-0433, TROG 03.08, SC20

Objectives

Primary

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

Secondary

1. Compare overall pain relief in patients treated with these regimens.
2. Compare time to pain progression in patients treated with these regimens.
3. Correlate initial irradiation response with pain relief after re-irradiation in these patients.
4. Compare changes in functional interference after re-irradiation using the Brief Pain Inventory in patients treated with these regimens.
5. Compare quality of life of patients treated with these regimens (patients in Canada, the Netherlands, and patients registered through RTOG).
6. Compare characteristics of non-responders (to both initial and re-irradiation) among patients treated with these regimens.
7. Compare the incidence of acute severe radiation-related side effects in patients treated with these regimens.
8. Compare the incidence of in-field pathological fractures and spinal cord compression in patients treated with these regimens.

Entry 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 site of pain for palliative radiotherapy must be smaller or similar in size to initial treatment field



• No clinical or radiological evidence of pathological fractures in extremities of the area to be re-irradiated, meeting either of the following criteria:
  • Not a candidate for surgical intervention
  • Candidate for surgical intervention AND no high-risk lytic lesion > 3 cm OR > 50% cortical erosion of bone diameter



• No clinical or radiological evidence of spinal cord compression

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
  • 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 intitial treatment did not cross midline
• 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

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

Expected Enrollment

A total of 650 patients (325 per treatment arm) will be accrued for this study.

Outcomes

Pain relief measured by the Brief Pain Inventory at 2 months after treatment

Quality of life assessed by the EORTC QLQ-C30

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. 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

Chow E, Hoskin PJ, Wu J, et al.: 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) 18 (2): 125-8, 2006.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

NCIC-Clinical Trials Group

Edward Chow, MD, Protocol chair		Ph: 416-480-4998
Jackson Wu, MD, FRCPC, Protocol co-chair		Ph: 403-521-3095

Radiation Therapy Oncology Group

William Hartsell, MD, Protocol chair		Ph: 847-981-5760

U.S.A.
California
	Burbank
	Providence Saint Joseph Medical Center - Burbank
		Clinical Trials Office - Providence Saint Joseph Medical Center - Burbank	Ph:  818-847-3220
	Castro Valley
	East Bay Radiation Oncology Center
		James Feusner, MD	Ph:  510-428-3689
	Eden Medical Center
		James Feusner, MD	Ph:  510-428-3689
	Valley Medical Oncology Consultants - Castro Valley
		James Feusner, MD	Ph:  510-428-3689
	Chico
	Enloe Cancer Center at Enloe Medical Center
		Clinical Trials Office - Enloe Cancer Center at Enloe Medical Center	Ph:  530-332-3808
	Fremont
	Valley Medical Oncology
		James Feusner, MD	Ph:  510-428-3689
	Martinez
	Contra Costa Regional Medical Center
		James Feusner, MD	Ph:  510-428-3689
	Oakland
	Alta Bates Summit Medical Center - Summit Campus
		Clinical Trials Office - Alta Bates Summit Medical Center - Summit Campus	Ph:  510-204-1414
	Bay Area Breast Surgeons, Incorporated
		James Feusner, MD	Ph:  510-428-3689
	CCOP - Bay Area Tumor Institute
		James Feusner, MD	Ph:  510-428-3689
	Highland General Hospital
		James Feusner, MD	Ph:  510-428-3689
	Larry G Strieff MD Medical Corporation
		James Feusner, MD	Ph:  510-428-3689
	Tom K Lee, Incorporated
		James Feusner, MD	Ph:  510-428-3689
	Pleasanton
	Valley Care Medical Center
		James Feusner, MD	Ph:  510-428-3689
	Valley Medical Oncology Consultants - Pleasanton
		James Feusner, MD	Ph:  510-428-3689
	Pomona
	Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
		Clinical Trials Office - Robert and Beverly Lewis Family Cancer Care Center	Ph:  909-865-9555
	Sacramento
	University of California Davis Cancer Center
		Clinical Trials Office - University of California Davis Cancer Center	Ph:  916-734-3089
	San Francisco
	UCSF Helen Diller Family Comprehensive Cancer Center
		Clinical Trials Office - UCSF Helen Diller Family Comprehensive Cancer Center	Ph:  877-827-3222
	San Pablo
	Doctors Medical Center - San Pablo Campus
		James Feusner, MD	Ph:  510-428-3689
Colorado
	Colorado Springs
	Penrose Cancer Center at Penrose Hospital
		Clinical Trials Office - Penrose Cancer Center	Ph:  719-776-5275
	Pueblo
	St. Mary - Corwin Regional Medical Center
		John Stageberg	Ph:  719-557-4000
Florida
	Gainesville
	University of Florida Shands Cancer Center
		Clinical Trials Office - University of Florida Shands Cancer Center	Ph:  888-254-7581
	Miami
	University of Miami Sylvester Comprehensive Cancer Center - Miami
		University of Miami Sylvester Comprehensive Cancer Center Clinical Trial Matching Service	Ph:  866-574-5124
			Email: Sylvester@emergingmed.com
Georgia
	Gainesville
	Northeast Georgia Medical Center
		Frank Lake, MD	Ph:  770-535-3393
Illinois
	Alton
	Saint Anthony's Hospital at Saint Anthony's Health Center
		Bethany Sleckman, MD	Ph:  314-251-7057
	Barrington
	Good Shepherd Hospital
		John Chang, MD	Ph:  847-723-8030
	Chicago
	Creticos Cancer Center at Advocate Illinois Masonic Medical Center
		Clinical Trials Office - Creticos Cancer Center at Advocate Illinois Masonic Medical Center	Ph:  773-296-5360
	John H. Stroger, Jr. Hospital of Cook County
		Nathanial Holloway	Ph:  312-864-3200
	Downers Grove
	Good Samaritan Cancer Care Center at Advocate Good Samaritan Hospital
		Clinical Trials Office - Good Samaritan Cancer Care Center at Advocate Good Samaritan Hospital	Ph:  630-275-1270
	Elk Grove Village
	Alexian Brothers Radiation Oncology
		Martin Boyer, MD	Ph:  847-981-5760
	Mt. Vernon
	Good Samaritan Regional Health Center
		Bethany Sleckman, MD	Ph:  314-251-7057
	Park Ridge
	Advocate Lutheran General Cancer Care Center
		Clinical Trials Office - Advocate Lutheran General Cancer Care Center	Ph:  847-384-3621
Indiana
	Anderson
	Saint John's Cancer Center at Saint John's Medical Center
		Darrel Ross	Ph:  765-646-8459
	Elkhart
	Elkhart General Hospital
		Janaki Moni, MD	Ph:  517-367-5070
	Fort Wayne
	Parkview Regional Cancer Center at Parkview Health
		David Hornback, MD	Ph:  574-647-7461
	Radiation Oncology Associates Southwest
		Tony Lee	Ph:  260-373-7850
	Indianapolis
	Indiana University Melvin and Bren Simon Cancer Center
		Clinical Trials Office - Indiana University Cancer Center	Ph:  317-274-2552
	Veterans Affairs Medical Center - Indianapolis
		Achilles Fakiris	Ph:  317-554-0000 888-878-6889
	Kokomo
	Howard Community Hospital
		Janaki Moni, MD	Ph:  517-367-5070
	La Porte
	Center for Cancer Therapy at LaPorte Hospital and Health Services
		Janaki Moni, MD	Ph:  517-367-5070
	South Bend
	CCOP - Northern Indiana CR Consortium
		Janaki Moni, MD	Ph:  517-367-5070
	Memorial Hospital of South Bend
		Clinical Trials Office - Memorial Hospital of South Bend	Ph:  800-284-7370
	Saint Joseph Regional Medical Center
		Janaki Moni, MD	Ph:  517-367-5070
	South Bend Clinic
		Janaki Moni, MD	Ph:  517-367-5070
Kansas
	Kansas City
	Providence Medical Center
		Rakesh Gaur, MD	Ph:  816-823-0555
	Lawrence
	Lawrence Memorial Hospital
		Rakesh Gaur, MD	Ph:  816-823-0555
	Overland Park
	Johnson County Radiation Therapy
		Rakesh Gaur, MD	Ph:  816-823-0555
	Menorah Medical Center
		Rakesh Gaur, MD	Ph:  816-823-0555
	Shawnee Mission
	Shawnee Mission Medical Center
		Rakesh Gaur, MD	Ph:  816-823-0555
Kentucky
	Lexington
	Lucille P. Markey Cancer Center at University of Kentucky
		Clinical Trials Office - Markey Cancer Center at University of Kentucky Chandler Medical Center	Ph:  859-257-3379
	Louisville
	James Graham Brown Cancer Center at University of Louisville
		George Spanos	Ph:  502-562-4158 866-530-5516
Massachusetts
	Boston
	Boston University Cancer Research Center
		Clinical Trials Office - Boston University Cancer Research Center	Ph:  617-353-7571
Michigan
	Adrian
	Hickman Cancer Center at Bixby Medical Center
		Clinical Trials Office - Hickman Cancer Center at Bixby Medical Center	Ph:  517-265-0116
	Ann Arbor
	University of Michigan Comprehensive Cancer Center
		Clinical Trials Office - University of Michigan Comprehensive Cancer Center	Ph:  800-865-1125
	Escanaba
	Green Bay Oncology, Limited - Escanaba
		Gregory Cooley, MD	Ph:  414-433-8184
	Iron Mountain
	Dickinson County Healthcare System
		Gregory Cooley, MD	Ph:  414-433-8184
	Kalamazoo
	Borgess Medical Center
		Raymond Lord, MD	Ph:  269-373-7458
	Bronson Methodist Hospital
		Raymond Lord, MD	Ph:  269-373-7458
	West Michigan Cancer Center
		Clinical Trials Office - West Michigan Cancer Center	Ph:  269-373-7458
	Lambertville
	Haematology-Oncology Associates of Ohio and Michigan, PC
		Paul Schaefer, MD	Ph:  419-479-5605
	Monroe
	Community Cancer Center of Monroe
		Paul Schaefer, MD	Ph:  419-479-5605
	Mercy Memorial Hospital - Monroe
		Paul Schaefer, MD	Ph:  419-479-5605
	Southfield
	Providence Cancer Institute at Providence Hospital - Southfield Campus
		June Chan	Ph:  248-849-3541 800-341-0801
	St. Joseph
	Lakeland Regional Cancer Care Center - St. Joseph
		Janaki Moni, MD	Ph:  517-367-5070
Minnesota
	Saint Cloud
	CentraCare Clinic - River Campus
		Barbi Kaplan-Frenkel, DO	Ph:  320-229-4901
	Coborn Cancer Center
		Barbi Kaplan-Frenkel, DO	Ph:  320-229-4901
Missouri
	Cape Girardeau
	Saint Francis Medical Center
		Bethany Sleckman, MD	Ph:  314-251-7057
	Gape Girardeau
	Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
		Bethany Sleckman, MD	Ph:  314-251-7057
	Independence
	Independence Regional Health Center
		Rakesh Gaur, MD	Ph:  816-823-0555
	Kansas City
	CCOP - Kansas City
		Rakesh Gaur, MD	Ph:  816-823-0555
	Kansas City Cancer Center at St. Joseph's Medical Mall
		Rakesh Gaur, MD	Ph:  816-823-0555
	North Kansas City Hospital
		Rakesh Gaur, MD	Ph:  816-823-0555
	Parvin Radiation Oncology
		Rakesh Gaur, MD	Ph:  816-823-0555
	Radiation Oncology Associates of Kansas City at Northland Radiation Oncology Center
		Rakesh Gaur, MD	Ph:  816-823-0555
	Research Medical Center
		Rakesh Gaur, MD	Ph:  816-823-0555
	Saint Luke's Cancer Institute at Saint Luke's Hospital
		Rakesh Gaur, MD	Ph:  816-823-0555
	St. Joseph Medical Center
		Rakesh Gaur, MD	Ph:  816-823-0555
	Truman Medical Center - Hospital Hill
		Rakesh Gaur, MD	Ph:  816-823-0555
	Saint Joseph
	Heartland Regional Medical Center
		Rakesh Gaur, MD	Ph:  816-823-0555
	Saint Louis
	CCOP - St. Louis-Cape Girardeau
		Bethany Sleckman, MD	Ph:  314-251-7057
	David C. Pratt Cancer Center at St. John's Mercy
		Clinical Trials Office - David C. Pratt Cancer Center at St. John's Mercy	Ph:  314-251-6770
Nebraska
	Kearney
	Good Samaritan Cancer Center at Good Samaritan Hospital
		Clinical Trials Office - Good Samaritan Cancer Center at Good Samaritan Hospital	Ph:  308-865-7963
	Omaha
	Methodist Estabrook Cancer Center
		Tien-Shew Huang	Ph:  402-354-5890 877-850-3212
New Hampshire
	Keene
	Kingsbury Center for Cancer Care at Cheshire Medical Center
		Alan Hartford, MD, PhD	Ph:  603-650-6600
	Lebanon
	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
		Clinical Trials Office - Norris Cotton Cancer Center	Ph:  603-650-7609
			Email: cancerhelp@dartmouth.edu
New Jersey
	Camden