Feasibility of Adaptive Radiation Therapy for Human-papilloma Virus-positive Oropharyngeal Cancer Patients on MRIdian Linac
NCT ID: NCT05849142
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2024-12-01
2024-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MRIdian Linac Group
All accrued participants will be enrolled onto the MRIdian Linac Group. Participants will receive adaptive radiotherapy (ART) on the MRIdian Linac. Participants will complete the duration of their radiotherapy regimen on the MRIdian Linac for approximately 7 weeks.
MRIdian Linac
Radiation therapy (RT) will be delivered with an integrated MRI-RT delivery system (MRIdian Linac). Participants will then receive standard-of-care RT with a dose prescription of 70 Gy in 35 fractions on the MRIdian Linac. Adaptive RT (ART) planning will occur every 5th fraction of RT.
Interventions
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MRIdian Linac
Radiation therapy (RT) will be delivered with an integrated MRI-RT delivery system (MRIdian Linac). Participants will then receive standard-of-care RT with a dose prescription of 70 Gy in 35 fractions on the MRIdian Linac. Adaptive RT (ART) planning will occur every 5th fraction of RT.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* American Joint Committee on Cancer (AJCC) 8th edition Stage I-III planned for definitive chemoradiation.
* Members of all races and ethnic backgrounds
* Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for duration of study participation.
* Must be able to understand and sign an Institutional Review Board (IRB)-approved written informed consent document.
Exclusion Criteria
* Prior history of cancer other than non-melanomatous skin cancer
* Distant metastases (cM1) or (pM1) disease)
* Evidence of a compromised airway
* Medical contraindications to MRIs
* Unable to tolerate MRIs without sedation
* Pregnant patients
* Breastfeeding patients
* Eastern Cooperative Oncology Group (ECOG) performance status \>1
18 Years
ALL
No
Sponsors
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University of Miami
OTHER
Responsible Party
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Stuart Samuels
Associate Professor of Clinical Medicine
Principal Investigators
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Stuart Samuels, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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The University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Countries
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Other Identifiers
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20220776
Identifier Type: -
Identifier Source: org_study_id
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