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Trial record 1 of 1 for:    NCT01255748
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Registry Study for Radiation Therapy Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01255748
Recruitment Status : Recruiting
First Posted : December 7, 2010
Last Update Posted : April 3, 2020
Information provided by (Responsible Party):
Proton Collaborative Group

Tracking Information
First Submitted Date December 6, 2010
First Posted Date December 7, 2010
Last Update Posted Date April 3, 2020
Study Start Date June 2009
Estimated Primary Completion Date June 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 16, 2018)
Define outcomes for patients treated at participating institutions [ Time Frame: PRN ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: December 17, 2012)
  • Determine strategies necessary to improve patients outcome and decrease toxicities related to treatments and procedures [ Time Frame: Annually PRN ]
  • Improve patient care by an adequate understanding of the results and patient population at participating institutions [ Time Frame: Reviewed Annually PRN ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Registry Study for Radiation Therapy Outcomes
Official Title Evaluation Tracking Project: A Prospective Chart Review of Patients Treated With Radiation Therapy
Brief Summary The purpose of this research study is to collect and analyze information from patients being treated with various forms of radiation therapy.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 30 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Radiation Oncology patients
Condition Solid Tumors
Intervention Radiation: Proton Therapy, Photon Therapy, SRS, Brachytherapy
Outcomes Tracking
Study Groups/Cohorts Treatment with Radiation Therapy
Includes 9 different arms to capture patient data by disease site
Intervention: Radiation: Proton Therapy, Photon Therapy, SRS, Brachytherapy
Publications * Lee HJ Jr, Macomber MW, Spraker MB, Bowen SR, Hippe DS, Fung A, Russell KJ, Laramore GE, Rengan R, Liao J, Apisarnthanarax S, Zeng J. Early toxicity and patient reported quality-of-life in patients receiving proton therapy for localized prostate cancer: a single institutional review of prospectively recorded outcomes. Radiat Oncol. 2018 Sep 17;13(1):179. doi: 10.1186/s13014-018-1127-6.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 16, 2018)
Original Estimated Enrollment
 (submitted: December 6, 2010)
Study Completion Date Not Provided
Estimated Primary Completion Date June 2029   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Planned treatment with radiation therapy
  • Ability to understand and sign IRB approved consent
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contact: Tish Adams, MS, CCRC, CP 913-788-6429
Contact: Matthew Morocco, BS 630-836-8670
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT01255748
Other Study ID Numbers REG001-09
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Proton Collaborative Group
Study Sponsor Proton Collaborative Group
Collaborators Not Provided
Study Chair: Carlos Vargas, MD Proton Collaborative Group
PRS Account Proton Collaborative Group
Verification Date July 2019