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Role of Ablative Radiotherapy in the Management of Metastatic Disease: A Patient Data Registry

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ClinicalTrials.gov Identifier: NCT04085029
Recruitment Status : Recruiting
First Posted : September 11, 2019
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Description
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Brief Summary:
The purpose of this study is to provide a registry of participants in order to assess the acute adverse event rates following ablative radiotherapy for metastatic disease.

Condition or disease
Oligometastasis Metastatic Cancer

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Role of Ablative Radiotherapy in the Management of Metastatic Disease: A Patient Data Registry
Actual Study Start Date : August 28, 2019
Estimated Primary Completion Date : September 2029
Estimated Study Completion Date : September 2029
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of acute adverse events following radiotherapy [ Time Frame: 90 Days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients at any Duke University Health System Radiation Oncology treatment facility
Criteria

Inclusion Criteria:

  • Age ≥ 18 years of age
  • Radiographic evidence of metastatic disease (may include oligoprogression, oligorecurrence or oligometastasis) at the time of study enrollment
  • Planned to receive, currently receiving, or have completed hypofractionated image guided radiotherapy (ablative radiotherapy) to an extracranial site(s)
  • Patient must sign study-specific informed consent

Exclusion Criteria:

• None

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04085029


Contacts
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Contact: Jennifer Mewshaw, MS NP (919) 668 5211 jennifer.mewshaw@duke.edu

Locations
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United States, North Carolina
Duke Cancer Institute Cary Not yet recruiting
Cary, North Carolina, United States, 27518
Contact: Sebrina Wiggins, BSN MHA RN    919-576-8277    sebrina.wiggins@duke.edu   
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Jennifer Mewshaw    919-668-5211    Jennifer.Mewshaw@duke.edu   
Duke Women's Cancer Care Raleigh Not yet recruiting
Raleigh, North Carolina, United States, 27607
Contact: Sebrina Wiggins, BSN MHA RN    919-576-8277    sebrina.wiggins@duke.edu   
Duke Raleigh Hospital Not yet recruiting
Raleigh, North Carolina, United States, 27609
Contact: Sebrina Wiggins, BSN MHA RN    919-576-8277    sebrina.wiggins@duke.edu   
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Joseph Salama, MD Duke University
More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04085029    
Other Study ID Numbers: Pro00103137
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
Ablative radiotherapy
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes