Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2
14 participants
INTERVENTIONAL
2017-01-04
2025-07-01
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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Proton Therapy and Chemotherapy
Standard chemoradiation using 5-FU, Mitomycin, with pencil beam proton radiotherapy
Proton therapy
Primary target volume 50.4-54 CGE in 28-30 fractions; Nodal volumes 42-54 CGE in 28-30 fractions
Chemotherapy
5FU 1000 mg/m2/day as 96 hour infusion days 1-5 and 29-33; Mitomycin 10mg/m2 days 1 and 29
Interventions
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Proton therapy
Primary target volume 50.4-54 CGE in 28-30 fractions; Nodal volumes 42-54 CGE in 28-30 fractions
Chemotherapy
5FU 1000 mg/m2/day as 96 hour infusion days 1-5 and 29-33; Mitomycin 10mg/m2 days 1 and 29
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically documented squamous or basaloid carcinoma of the anal canal
* Stage T2-4 disease with any N category
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Jordan Kharofa
OTHER
Responsible Party
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Jordan Kharofa
Assistant Professor
Principal Investigators
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Jordan Kharofa, MD
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Locations
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UC Health
Cincinnati, Ohio, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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UCCI-GI-16-01
Identifier Type: -
Identifier Source: org_study_id
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