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Tipton KN, Sullivan N, Bruening W, et al. Stereotactic Body Radiation Therapy [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2011 May. (Comparative Effectiveness Technical Briefs, No. 6.)

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Stereotactic Body Radiation Therapy [Internet].

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Appendix KOngoing Clinical Trials

Ongoing Clinical Trials

ConditionClinicalTrials.gov IdentifierStudy DesignInterventionPrimary Outcome MeasuresSecondary Outcome MeasuresEstimated EnrollmentPlanned DurationLocation
Breast Cancer, MetastaticNCT00167414Nonrandomized; historical controlHSBRTOS, DFSCRR, chemical and radiobiological response, QoL80December 2000– OngoingRochester, NY
Cholangiocarcinoma Klatskin Tumor Biliary Tract CancerNCT00630890Single groupExternal beam radiation and CyberKnife radiosurgery boost and capecitabineAcute toxicities, MTDLC, radiographic response, delayed and long-term toxicities, DSS, OS11October 2007– October 2011San Francisco, CA
CholangiocarcinomaNCT00983541Single groupSBRT, brachytherapy, fluorouracil (5-FU), gemcitabineToxicityOS, PFS, tumor response, LC, rate of distant mets12September 2009– September 2011Salt Lake City, UT
Colorectal Cancer (fewer than 5 metastases)NCT00807313Single groupSBRTMetabolic complete remission rateToxicity, PFS, LC, OS81December 2008– OngoingBrussels, Belgium
Hepatocellular CarcinomaNCT00746655Single groupSBRT with TACEFeasibility and toxicityLC, RC, HRQoL12July 2009– OngoingUniversity of Pittsburgh, Pittsburgh, PA
Hepatocellular CarcinomaNCT00914355Single groupSBRTLocal PFSPFS, OS, QoL, toxicity, cytokine response47August 2007– August 2010Toronto, Canada
Hepatocellular CarcinomaNCT00243841NonrandomizedSBRT6 month LCNot specified60May 2004– December 2015Indianapolis, IN
Hepatocellular CarcinomaNCT01020812Single groupSBRT with TACEEfficacy, toxicityPFS, OS, correlate tumor marker alpha-fetoprotein (AFP) with tumor response and survival24September 2009– September 2013Stanford, CA
Kidney CancerNCT00445757Single groupConventional surgery; neoadjuvant therapy; SRSMTD, toxicityDFS, LP, DF, DSS20January 2007– January 2012Cleveland, OH
Kidney CancerNCT00458484Single groupSRSMTDOS, DFS, LP, DF32February 2007– February 2012Cleveland, OH
Liver CancerNCT01030757Single groupSBRT with TomotherapyTumor responseToxicity, PFS, OS43June 2009– January 2014Albuquerque, NM
Liver CancerNCT00607828Single groupSBRTToxicity, MTDNot specified28November 2007– October 2009Omaha, NE
Liver CancerNCT00777894Single groupSBRT; Three- dimensional RT; IMRTDose limiting toxicity; objective responseAdverse events, tumor response, PFS, OS, Child- Pugh Score73November 2008– March 2012Haifa, Israel; Jerusalem, Israel; Masstricht, Netherlands; Aarau, Switzerland; Zurich, Switzerland; Bellinzona; Switzerland; Bern, Switzerland; St. Gallen, Switzerland; Basel, Switzerland
Liver CancerNCT006078281Single groupSBRTToxicity, MTDNS28November 2007– October 2009Omaha, NE
Liver MetastasesNCT00914615Single groupSBRTLocal PFSPFS, OS, QoL, toxicity, cytokine response17August 2007– August 2010Toronto, Canada
Liver MetastasesNCT00938457Single groupSBRTMTD, minimum effective doseAdverse events, toxicity, tumor response, LC, time to progression, blood chemistry and hepatic function60July 2009– November 2017Rochester, MN
Primary and Metastatic Liver TumorsNCT00691691Single groupSBRTCRRToxicity71November 2007– November 2008Calgary, Alberta, Canada
Liver MetastasesNCT005679701Single groupSBRTMTDToxicity; adverse events; QoL; Response; physical exam results18April 2007– October 2008Jacksonville, FL
Liver MetastasesNCT00547677Single groupSBRTToxicityTumor response27July 2004– December 2007Dallas, TX; Minneapolis, MN
Lung and Liver TumorsNCT001784771Single groupSBRTNSNS48January 2002– January 2006Rochester, NY
Lung TumorsNCT00632281Single groupSBRTDisease statusToxicity750January 2006– OngoingUniversity of Florida, Gainesville, FL
Lung TumorsNCT00832780Single groupSBRT using TomotherapyCRR (complete and partial)45January 2008– October 2011University of New Mexico, Albuquerque, NM
Lung CancerNCT00238602Single groupSRS (CyberKnife)MTD, symptoms and radiographic responsesNR60March 2000– OngoingStanford, CA
Lung CancerNCT00687986RandomizedSRT vs. Primary ResectionLC, RC, QoL; treatment costsOS; QALY; total costs960August 2008– December 2013Amsterdam, Netherlands
Lung CancerNCT01051037Single groupSBRT and radiofrequency ablationToxicityOne year LC, PFS, OS35January 2010– January 2013Los Angeles, CA
Non-small Cell Lung CancerNCT00643318Single groupCyberKnife SRSCRR, LCR, PFS, OSQoL, procedures related outcomes156April 2006– July 2013Pittsburgh, PA
Non-small Cell Lung CancerNCT008701163-group comparison (nonrandomized)SBRT (CyberKnife) vs. SBRT (linac) vs. Conformational RTLCEconomic, QoL, PFS, OS120April 2009– March 2013Multiple centers, France
Non-small Cell Lung CancerNCT00551369Single groupSBRT followed by surgical resection in patients with progressionLCToxicity, LC, RC, DFS, OS33December 2007– June 2012Multicenter, U.S. and Canada
Non-small Cell Lung CancerNCT00843726RandomizedSBRT—one vs. three fractionsToxicity, OSNS98September 2008– April 2013Roswell Park Cancer Institute, New York, NY
Non-small Cell Lung CancerNCT000874382Single groupSBRTLCRC, DFS, OS52May 2004– March 2009University of Rochester, Rochester, NY
Non-small Cell Lung CancerNCT00547105Single groupErlotinib hydrochloride and SBRTPFSDisease progression, Toxicity, OS24June 2007– June 2010University of Texas, Dallas, TX
Non-small Cell Lung CancerNCT00238875Single groupSBRTOS at 3 yearsRFS, Toxicity, PFS, OS167July 2004– November 2011Multiple sites, Japan
Non-small Cell Lung CancerNCT00591838Single groupSBRTToxicityLC, RC, DFS, OS45August 2006– August 2016Washington University Hospital, St. Louis, MO
Non-small Cell Lung CancerNCT00727350Single group, historical controlSBRTToxicityLC, OS, DFS, PFS, QoL44March 2007– December 2012Brussels, Belgium
Non-small Cell Lung Cancer (Stage I, Stage II, or peripheral lung recurrence)NCT00489008Three uncontrolled groupsSBRTDFS, OSNot reported138November 2005– September 2012M.D. Anderson Cancer Center, Houston, TX
Non-small Cell Lung CancerNCT00750269Single groupSBRTToxicityLC, PFS, OS94February 2009– May 2012Multiple sites, U.S. and Canada
Non-small Cell Lung CancerNCT00840749Randomized, open labelSBRT vs. surgical resectionOSDSS, PFS, Toxicity1,030December 2008– December 2013Multiple sites, U.S. and China
Non-small Cell Lung CancerNCT002461811Single groupSBRTDosageEfficacy117December 1999– December 2009Indianapolis, IN
Pancreatic NeoplasmsNCT00833859Single groupSBRT and Gemcitabine, Docetaxel and CapecitabineRate of surgical resection with negative marginsToxicity, OS24March 2009– March 2012Tampa, FL
Pancreatic CancerNCT003501421Single group, historical controlSBRTOS, QoLNS40December 2004– October 2008 (completed)Stanford University, Stanford, CA
Pancreatic CancerNCT00425841Single groupGemcitabine hydrochloride, oxaliplatin, adjuvant therapy, hypofractionated radiation therapy, neoadjuvant therapy, SRSCRRToxicity, time to progression, time to death, tumor response29May 2006–NS1Munich, Germany
Pancreatic CancerNCT01068327Single groupSBRT, gemcitabine hydrochloride, leucovorin calcium, fluorouracil, nelfinavir mesylate; conventional surgeryDose limiting toxicity, MTDTumor response;24November 2007– December 2012Omaha, NE
Pancreatic CancerNCT01025882Single groupSBRT, gemcitabine hydrochloride, pancreato- duodenectomyToxicity, morbidity, tumor response, length of hospital stayNS30October 2009– October 2014Dallas, TX
Prostate CancerNCT00643617Single groupCyberKnife SRSBiochemical DFS, rates of acute and late gastro- intestinal and genitourinary toxicitiesLF, DF, DFS, DSS, OS, QoL253November 2007– January 2014San Diego, CA; Fresno, CA; Great Falls, MT; Oklahoma City, OK; Tyler, TX
Prostate CancerNCT00619515Single groupSRSRate of acute toxicitiesRate of late grade 3–5 toxicities, DFS, OS, LF, DF, QoL102December 2007– December 2009Cleveland, OH; Chardnor, OH; Mentor, OH; Canton, OH; South Euclid, OH; Orange Village, OH; Westlake, OH; Middleburgh Heights; OH
Prostate CancerNCT00643994Single groupCyberKnife SRSRates of acute and late grade 3–5 gastro- intestinal and genitourinary toxicities, rate of biochemical DFSLF, DF, DFS, DSS, OS, QoL298December 2007– January 2014Jupiter, FL; Arlington Heights, IL; Lexington, KY; Boston, MA; Ann Arbor, MI; Trenton, NJ; Seattle, WA
Prostate CancerNCT00941915Single groupSBRT with continuous real- time evaluation of prostate motion and IMRT for plan reoptimization based on “anatomy of the day”ToxicityDFS, QoL60September 2009– December 2012Duke University, Durham, NC
Prostate CancerNCT00547339Single groupSBRTToxicityOS, LC, RC, DSS97July 2006– October 2010University of Texas, Dallas, TX
Prostate CancerNCT01059513Single groupSBRTLong term toxicities; tumor controlNot specified60January 2010– January 2017Los Angeles, CA
Unspecified Adult Solid TumorNCT00311597Single groupSRSMTD, MDRadiographic response rate, median time to progression, toxicity, cause of death48June 2002– OngoingWinston-Salem, NC
Extracranial Recurrent, Metastatic Cancer or Primary TumorsNCT000064561Single groupSRSNRNR10–25 within 2–3 yearsFebruary 1999– OngoingRichmond, VA
1

Although the estimated completion date has expired, the trial is still ongoing and “active” according to ClinicalTrials.gov at the time of this report.

2

This study has been completed and results have been published. See Appendix L. Literature Results.109

CRR: Clinical response rate

DF: Distant failure

DFS: Disease-free survival

DSS: Disease-specific survival

HRQoL: Health-related quality of life

HSBRT: Hypofractionated stereotactic body radiotherapy

IMRT: Intensity modulated radiation therapy

LC: Local control

LCR: Local control rate

LF: Local failure

LP: Local progression

M: Male

MD: Minimum dose

MTD: Maximum tolerated dose

NS: Not specified

OS: Overall survival

PFS: Progression-free survival

QALY: Quality-adjusted life years

QoL: Quality of life

RC: Regional control

RT: Radiation therapy

SBRT: Stereotactic body radiation therapy

SRS: Stereotactic radiosurgery

TACE: Transcatheter arterial chemoembolization

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