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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00003162
Other study ID # RTOG-9714
Secondary ID CDR0000065957NCC
Status Completed
Phase Phase 3
First received November 1, 1999
Last updated November 14, 2015
Start date February 1998

Study information

Verified date November 2015
Source Radiation Therapy Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which radiation therapy regimen is more effective for bone metastases.

PURPOSE: Randomized phase III trial to compare different radiation therapy regimens in treating patients who have bone metastases from breast or prostate cancer.


Description:

OBJECTIVES:

- Compare the ability of a single fraction of radiation therapy vs multiple fractions to provide complete pain relief in patients with painful bone metastases from breast or prostate cancer.

- Determine the frequency and duration of pain relief and narcotic relief after these treatments in these patient populations.

- Compare the effect on quality of life of these two treatments in these patient populations.

- Compare the incidence of pathologic fracture within the treatment fields after these two treatments in these patient populations.

OUTLINE: This is a randomized study.

Patients are assigned to 1 of 2 treatment arms. Arm I consists of radiation therapy delivered in 10 fractions over 2 weeks. Arm II consists of a single dose of radiation therapy. Any retreatment does not occur until at least 4 weeks after prior treatment unless there is an increase of 2 points on the pain score.

Patients are followed and quality of life is assessed at 2 and 4 weeks, then at 2, 3, 6, 9, and 12 months, every 6 months for the next 3 years, then annually until death.

PROJECTED ACCRUAL: This study will accrue 938 patients within 2 years.


Recruitment information / eligibility

Status Completed
Enrollment 949
Est. completion date
Est. primary completion date July 2003
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility DISEASE CHARACTERISTICS:

- Histologically proven breast or prostate cancer

- Radiographic evidence of bone metastasis within 8 weeks of study

- Eligible treatment sites:

- Weight-bearing sites:

- Pelvis (excluding pubis)

- Femur

- Sacrum and/or sacroiliac joints

- Tibia

- Non-weight-bearing sites:

- Up to 5 consecutive cervical, thoracic, or lumbar vertebral bodies

- Lumbosacral spine

- Up to 3 consecutive ribs

- Humerus

- Fibula

- Radius with/without ulna

- Clavicle

- Scapula

- Pubis

- If multiple sites are treated, site is included as weight bearing if any of the sites include the pelvis, sacrum, femur, or tibia

- Worst pain score of at least 5 on a scale of 10

- No skull, feet, or hand metastases

- No spinal cord or cauda equina compression/effacement in vertebral metastases

- Multiple sites eligible if they can be included in no greater than 3 treatment sites

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 40-100%

Life expectancy:

- At least 3 months

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

Other:

- No impending fracture of the treatment site

- No hematologic primary malignancies

- Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No change in immunotherapy within 30 days

Chemotherapy:

- No change in chemotherapy within 30 days

Endocrine therapy:

- No change in hormonal therapy within 30 days

Radiotherapy:

- No prior radiation therapy to treatment area

- At least 30 days since systemic radiotherapy (Sr 89)

Surgery:

- No prior palliative surgery to treatment area

- No planned surgical fixation of the bone

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Intervention

Procedure:
pain therapy

Radiation:
radiation therapy


Locations

Country Name City State
Canada Tom Baker Cancer Center - Calgary Calgary Alberta
Canada Cross Cancer Institute Edmonton Alberta
Canada CHUS-Hopital Fleurimont Fleurimont Quebec
Canada Nova Scotia Cancer Centre Halifax Nova Scotia
Canada Cancer Care Ontario-Hamilton Regional Cancer Centre Hamilton Ontario
Canada Kingston Regional Cancer Centre Kingston Ontario
Canada Cancer Care Ontario-London Regional Cancer Centre London Ontario
Canada Centre Hospitalier de l'Universite de Montreal Montreal Quebec
Canada McGill University Montreal Quebec
Canada Ottawa Regional Cancer Centre Ottawa Ontario
Canada Centre Hospitalier Universitaire de Quebec Quebec City Quebec
Canada Allan Blair Cancer Centre Regina Saskatchewan
Canada Saint John Regional Hospital Saint John New Brunswick
Canada Saskatoon Cancer Centre Saskatoon Saskatchewan
Canada Newfoundland Cancer Treatment and Research Foundation St. Johns Newfoundland and Labrador
Canada Northeastern Ontario Regional Cancer Centre, Sudbury Sudbury Ontario
Canada Northwestern Ontario Regional Cancer Centre, Thunder Bay Thunder Bay Ontario
Canada Princess Margaret Hospital Toronto Ontario
Canada Toronto Sunnybrook Regional Cancer Centre Toronto Ontario
United States Akron City Hospital Akron Ohio
United States Akron General Medical Center Akron Ohio
United States Cancer Center of Albany Medical Center Albany New York
United States Radiation Oncology Associates of Albuquerque Albuquerque New Mexico
United States Lehigh Valley Hospital Allentown Pennsylvania
United States Harrington Cancer Center Amarillo Texas
United States St. John's Medical Center Anderson Indiana
United States CCOP - Ann Arbor Regional Ann Arbor Michigan
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Anne Arundel Oncology Center Annapolis Maryland
United States Northwest Community Hospital Arlington Heights Illinois
United States CCOP - Atlanta Regional Atlanta Georgia
United States Emory University Hospital - Atlanta Atlanta Georgia
United States Greater Baltimore Medical Center and Cancer Center Baltimore Maryland
United States Harbor Hospital Center Baltimore Maryland
United States Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland
United States Sinai Hospital of Baltimore Baltimore Maryland
United States Mary Bird Perkins Cancer Center Baton Rouge Louisiana
United States Green Mountain Oncology Group Bennington Vermont
United States St. Luke's Hospital Regional Cancer Center Bethlehem Pennsylvania
United States CCOP - Montana Cancer Consortium Billings Montana
United States Lourdes Regional Cancer Center Binghamton New York
United States University of Alabama at Birmingham Comprehensive Cancer Center Birmingham Alabama
United States Medcenter One Health System Bismarck North Dakota
United States Bloomington Hospital Bloomington Indiana
United States New York Methodist Hospital Brooklyn New York
United States State University of New York Health Science Center at Brooklyn Brooklyn New York
United States Vermont Cancer Center Burlington Vermont
United States Cooper Cancer Institute Camden New Jersey
United States CCOP - Cedar Rapids Oncology Project Cedar Rapids Iowa
United States Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina
United States Cancer Center at the University of Virginia Charlottesville Virginia
United States Northwestern Memorial Hospital Chicago Illinois
United States Barrett Cancer Center, The University Hospital Cincinnati Ohio
United States Christ Hospital Cincinnati Ohio
United States Cleveland Clinic Foundation Cleveland Ohio
United States Cleveland Clinic Taussig Cancer Center Cleveland Ohio
United States Ireland Cancer Center Cleveland Ohio
United States University Hospitals of Cleveland Cleveland Ohio
United States Finger Lakes Radiation Oncology Center Clifton Springs New York
United States Memorial Hospital Cancer Center Colorado Springs Colorado
United States Ellis Fischel Cancer Center - Columbia Columbia Missouri
United States Arthur G. James Cancer Hospital - Ohio State University Columbus Ohio
United States CCOP - Columbus Columbus Ohio
United States Medical Center/John B. Amos Community Cancer Center Columbus Georgia
United States Mount Diablo Medical Center Concord California
United States Northeast Medical Center Concord North Carolina
United States Geisinger Medical Center Danville Pennsylvania
United States Mercy Fitzgerald Hospital Darby Pennsylvania
United States CCOP - Central Illinois Decatur Illinois
United States University of Colorado Cancer Center Denver Colorado
United States CCOP - Iowa Oncology Research Association Des Moines Iowa
United States Barbara Ann Karmanos Cancer Institute Detroit Michigan
United States Henry Ford Hospital Detroit Michigan
United States Delaware County Memorial Hospital Drexel Hill Pennsylvania
United States Cancer Center and Beckman Research Institute, City of Hope Duarte California
United States Wendt Regional Cancer Center of Finley Hospital Dubuque Iowa
United States Veterans Affairs Medical Center - East Orange East Orange New Jersey
United States Pocono Cancer Center East Stroudsburg Pennsylvania
United States John F. Kennedy Medical Center Edison New Jersey
United States Trinitas Hospital - Jersey Street Campus Elizabeth New Jersey
United States Hurley Medical Center Flint Michigan
United States McLaren Regional Cancer Center Flint Michigan
United States California Cancer Center Fresno California
United States Saint Agnes Cancer Center Fresno California
United States University of Florida Health Science Center Gainesville Florida
United States University of Texas Medical Branch Galveston Texas
United States Saint Mary's Hospital and Medical Center Grand Junction Colorado
United States CCOP - Green Bay Green Bay Wisconsin
United States St. Vincent Hospital Green Bay Wisconsin
United States Sutter Health West Cancer Research Group Greenbrae California
United States CCOP - Greenville Greenville South Carolina
United States East Carolina University School of Medicine Greenville North Carolina
United States RMH Regional Cancer Center Harrisonburg Virginia
United States Ingalls Memorial Hospital Harvey Illinois
United States Milton S. Hershey Medical Center Hershey Pennsylvania
United States MBCCOP - Hawaii Honolulu Hawaii
United States University of Texas - MD Anderson Cancer Center Houston Texas
United States Comprehensive Cancer Institute of Huntsville Huntsville Alabama
United States Huntsville Hospital System Huntsville Alabama
United States Cape Cod Hospital Hyannis Massachusetts
United States Clarian Health Partners Inc. Indianapolis Indiana
United States Regional Cancer Center Indianapolis Indiana
United States Veterans Affairs Medical Center - Indianapolis (Roudebush) Indianapolis Indiana
United States Jackson-Madison County General Hospital Jackson Tennessee
United States Edna Williams Cancer Treatment Center Jacksonville Florida
United States Mayo Clinic Jacksonville Florida
United States Veterans Affairs Medical Center - Boston (Jamaica Plain) Jamaica Plain Massachusetts
United States CCOP - Kalamazoo Kalamazoo Michigan
United States CCOP - Kansas City Kansas City Missouri
United States CCOP - Dayton Kettering Ohio
United States Gundersen Lutheran Medical Foundation La Crosse Wisconsin
United States Wilford Hall - 59th Medical Wing Lackland Air Force Base Texas
United States Oncology Institute of Greater Lafayette Lafayette Indiana
United States Kimball Medical Center Lakewood New Jersey
United States CCOP - Southern Nevada Cancer Research Foundation Las Vegas Nevada
United States Norris Cotton Cancer Center Lebanon New Hampshire
United States Albert B. Chandler Medical Center, University of Kentucky Lexington Kentucky
United States Central Baptist Hospital Lexington Kentucky
United States Lexington Clinic Cancer Center Lexington Kentucky
United States Loma Linda University Medical Center Loma Linda California
United States Veterans Affairs Medical Center - Long Beach Long Beach California
United States Monmouth Medical Center Long Branch New Jersey
United States Jonsson Comprehensive Cancer Center, UCLA Los Angeles California
United States USC/Norris Comprehensive Cancer Center and Hospital Los Angeles California
United States James Graham Brown Cancer Center Louisville Kentucky
United States Louisville Radiation Oncology Louisville Kentucky
United States Joe Arrington Cancer Research and Treatment Center Lubbock Texas
United States Southern Wisconsin Radiotherapy Center Madison Wisconsin
United States University of Wisconsin Comprehensive Cancer Center Madison Wisconsin
United States Merle M. Mahr Cancer Center Madisonville Kentucky
United States Elliot Regional Cancer Center Manchester New Hampshire
United States CCOP - North Shore University Hospital Manhasset New York
United States Marquette General Hospital Marquette Michigan
United States Marshfield Clinic Marshfield Wisconsin
United States Loyola University Medical Center Maywood Illinois
United States Health First Holmes Regional Medical Center Melbourne Florida
United States University of Tennessee, Memphis Cancer Center Memphis Tennessee
United States Community Memorial Hospital Menomonee Falls Wisconsin
United States Baptist Hospital of Miami Miami Florida
United States Sylvester Cancer Center, University of Miami Miami Florida
United States Veterans Affairs Medical Center - Miami Miami Florida
United States CCOP - Mount Sinai Medical Center Miami Beach Florida
United States MidMichigan Medical Center - Midland Midland Michigan
United States South Jersey Regional Cancer Center Millville New Jersey
United States Columbia Hospital Milwaukee Wisconsin
United States Medical College of Wisconsin Milwaukee Wisconsin
United States St. Luke's Medical Center Milwaukee Wisconsin
United States Trinity Cancer Care Center Minot North Dakota
United States MBCCOP - Gulf Coast Mobile Alabama
United States Alabama Oncology, LLC Montgomery Alabama
United States Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County Mount Holly New Jersey
United States Ball Memorial Hospital Muncie Indiana
United States Vanderbilt-Ingram Cancer Center Nashville Tennessee
United States Cancer Institute of New Jersey New Brunswick New Jersey
United States CCOP - Ochsner New Orleans Louisiana
United States MBCCOP - LSU Health Sciences Center New Orleans Louisiana
United States Tulane University School of Medicine New Orleans Louisiana
United States Herbert Irving Comprehensive Cancer Center New York New York
United States Memorial Sloan-Kettering Cancer Center New York New York
United States Newark Beth Israel Medical Center Newark New Jersey
United States CCOP - Bay Area Tumor Institute Oakland California
United States St. Anthony Hospital Oklahoma City Oklahoma
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States CCOP - Missouri Valley Cancer Consortium Omaha Nebraska
United States Methodist Cancer Center - Omaha Omaha Nebraska
United States Nebraska Health System Omaha Nebraska
United States MD Anderson Cancer Center Orlando Orlando Florida
United States Bay Medical Center Panama City Florida
United States Gulf Coast Cancer Treatment Center Panama City Florida
United States Lutheran General Cancer Care Center Park Ridge Illinois
United States Bayshore Medical Center Pasadena Texas
United States Huntington Cancer Center Pasadena California
United States CCOP - Illinois Oncology Research Association Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States Albert Einstein Cancer Center Philadelphia Pennsylvania
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia Pennsylvania
United States University of Pennsylvania Cancer Center Philadelphia Pennsylvania
United States Veterans Affairs Medical Center - Philadelphia Philadelphia Pennsylvania
United States Foundation for Cancer Research and Education Phoenix Arizona
United States Allegheny General Hospital Pittsburgh Pennsylvania
United States Mercy Hospital of Pittsburgh Pittsburgh Pennsylvania
United States University of Pittsburgh Cancer Institute Pittsburgh Pennsylvania
United States Western Pennsylvania Hospital Pittsburgh Pennsylvania
United States Champlain Valley Physicians Hospital Medical Center Plattsburgh New York
United States Atlantic City Medical Center Pomona New Jersey
United States Cancer Care Center Pomona California
United States CCOP - Columbia River Program Portland Oregon
United States Maine Medical Center Portland Maine
United States Naval Medical Center, Portsmouth Portsmouth Virginia
United States Vassar Brothers Hospital Poughkeepsie New York
United States Roger Williams Medical Center/BUSM Providence Rhode Island
United States All Saints Cancer Center Racine Wisconsin
United States Rex Healthcare Raleigh North Carolina
United States Rapid City Regional Hospital Rapid City South Dakota
United States Reading Hospital and Medical Center Reading Pennsylvania
United States Bon-Secours - St. Mary's Hospital Richmond Virginia
United States Massey Cancer Center Richmond Virginia
United States Valley Hospital Ridgewood New Jersey
United States Mayo Clinic Cancer Center Rochester Minnesota
United States University of Rochester Cancer Center Rochester New York
United States Regional Radiation Oncology Center at Rome Rome Georgia
United States William Beaumont Hospital Royal Oak Michigan
United States Radiation Oncology Center - Sacramento Sacramento California
United States Dixie Regional Medical Center Saint George Utah
United States Mallinckrodt Institute of Radiology Saint Louis Missouri
United States St. Louis University Health Sciences Center Saint Louis Missouri
United States CCOP - Metro-Minnesota Saint Louis Park Minnesota
United States Peninsula Regional Medical Center Salisbury Maryland
United States Latter Day Saints Hospital Salt Lake City Utah
United States University of Utah Health Sciences Center Salt Lake City Utah
United States Radiation Medical Group, Inc. San Diego California
United States UCSF Cancer Center and Cancer Research Institute San Francisco California
United States O'Connor Hospital San Jose California
United States CCOP - Santa Rosa Memorial Hospital Santa Rosa California
United States Sarasota Radiation and Medical Oncology Center Sarasota Florida
United States CCOP - Scottsdale Oncology Program Scottsdale Arizona
United States Mercy Hospital Cancer Center - Scranton Scranton Pennsylvania
United States Virginia Mason Medical Center Seattle Washington
United States North Shore Radiation Oncology Setauket New York
United States Siouxland Hematology-Oncology Sioux City Iowa
United States CCOP - Sioux Community Cancer Consortium Sioux Falls South Dakota
United States CCOP - Northern Indiana CR Consortium South Bend Indiana
United States CCOP - Upstate Carolina Spartanburg South Carolina
United States Deaconess Medical Center Spokane Washington
United States Cancer Research for the Ozarks Springfield Missouri
United States CCOP - Cancer Research for the Ozarks Springfield Missouri
United States St. Joseph's Regional Health System Stockton California
United States CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse New York
United States State University of New York - Upstate Medical University Syracuse New York
United States Tallahassee Memorial Healthcare Tallahassee Florida
United States H. Lee Moffitt Cancer Center and Research Institute Tampa Florida
United States CCOP - Toledo Community Hospital Oncology Program Toledo Ohio
United States Community Medical Center Toms River New Jersey
United States David Grant Medical Center Travis Air Force Base California
United States Capital Health System at Mercer Trenton New Jersey
United States St. Francis Medical Center Trenton New Jersey
United States William Beaumont Hospital - Troy Troy Michigan
United States St. John Health System Tulsa Oklahoma
United States Radiation Oncology Associates of West Alabama Tuscaloosa Alabama
United States CCOP - Carle Cancer Center Urbana Illinois
United States Associated Radiologists, P.A. Warren New Jersey
United States Howard University Cancer Center Washington District of Columbia
United States Waukesha Memorial Hospital Waukesha Wisconsin
United States Schiffler Cancer Center Wheeling West Virginia
United States CCOP - Wichita Wichita Kansas
United States Wilkes Barre General Hospital Wilkes-Barre Pennsylvania
United States CCOP - Christiana Care Health Services Wilmington Delaware
United States CCOP - Southeast Cancer Control Consortium Winston-Salem North Carolina
United States Comprehensive Cancer Center at Wake Forest University Winston-Salem North Carolina
United States Yakima Valley Memorial Hospital Yakima Washington
United States Riverhill Radiation Oncology Yonkers New York
United States York Hospital York Pennsylvania

Sponsors (3)

Lead Sponsor Collaborator
Radiation Therapy Oncology Group National Cancer Institute (NCI), North Central Cancer Treatment Group

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (12)

Bruner DW, Winter K, Hartsell W, et al.: Prospective health-related quality of life valuations (utilities) of 8 Gy in 1 fraction vs 30 Gy in 10 fractions for palliation of painful bone metastases: preliminary results of RTOG 97-14. [Abstract] Int J Radiat

Bruner DW. Outcomes research in cancer symptom management trials: the Radiation Therapy Oncology Group (RTOG) conceptual model. J Natl Cancer Inst Monogr. 2007;(37):12-5. — View Citation

Chow E, James J, Barsevick A, Hartsell W, Ratcliffe S, Scarantino C, Ivker R, Roach M, Suh J, Petersen I, Konski A, Demas W, Bruner D. Functional interference clusters in cancer patients with bone metastases: a secondary analysis of RTOG 9714. Int J Radia — View Citation

Hartsell WF, DeSilvio M, Bruner DW, et al.: Can physicians accurately predict survival time in patients with metastatic cancer? Analysis of RTOG 9714. [Abstract] Int J Radiat Oncol Biol Phys 60 (1 Suppl 1): A-25, S143, 2004.

Hartsell WF, Desilvio M, Bruner DW, Scarantino C, Ivker R, Roach M 3rd, Suh J, Demas WF, Movsas B, Petersen IA, Konski AA. Can physicians accurately predict survival time in patients with metastatic cancer? Analysis of RTOG 97-14. J Palliat Med. 2008 Jun; — View Citation

Hartsell WF, Scott C, Bruner DW, et al.: Phase III randomized trial of 8 Gy in 1 fraction vs. 30 Gy in 10 fractions for palliation of painful bone metastases: preliminary results of RTOG 97-14. [Abstract] Int J Radiat Oncol Biol Phys 57 (2 Suppl): S124, 2

Hartsell WF, Scott CB, Bruner DW, Scarantino CW, Ivker RA, Roach M 3rd, Suh JH, Demas WF, Movsas B, Petersen IA, Konski AA, Cleeland CS, Janjan NA, DeSilvio M. Randomized trial of short- versus long-course radiotherapy for palliation of painful bone metas — View Citation

Hartsell WF, Winter K, Bruner DW, et al.: Breast cancer patients have better outcomes than prostate cancer patients for palliation of painful bone metastases: results of RTOG 97-14. [Abstract] J Clin Oncol 23 (Suppl 16): A-6073, 546s, 2005.

Howell DD, James JL, Hartsell WF, et al.: Randomized trial of short-course versus long-course radiotherapy for palliation of painful vertebral bone metastases: A retrospective analysis of RTOG 97-14. [Abstract] J Clin Oncol 27 (Suppl 15): A-9521, 2009.

Juliano JJ, Reddy CA, Videtic GMM: How fast does practice change? A single-institution experience in utilization of a single fraction for palliation of bone metastases before and after RTOG 9714. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-2561, S521-2, 2006.

Konski A, Desilvio M, Hartsell W, Watkins-Bruner D, Coyne J, Scarantino C, Janjan N. Continuing evidence for poorer treatment outcomes for single male patients: retreatment data from RTOG 97-14. Int J Radiat Oncol Biol Phys. 2006 Sep 1;66(1):229-33. Epub — View Citation

Konski A, James J, Hartsell W, Leibenhaut MH, Janjan N, Curran W, Roach M, Watkins-Bruner D. Economic analysis of radiation therapy oncology group 97-14: multiple versus single fraction radiation treatment of patients with bone metastases. Am J Clin Oncol. 2009 Aug;32(4):423-8. doi: 10.1097/COC.0b013e31818da9f7. — View Citation

* Note: There are 12 references in allClick here to view all references

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