At a glance
ClinicalIndex Comparison RecordPhase 2Active· 14 enrolled
Drug / intervention
Chemotherapy +1 moredrug
Likely dose
Chemotherapy 1000 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective Pilot Study to Evaluate the Feasibility of Intensity Modulated Proton Therapy in Reducing Toxicity in Anal Cancer
In Brief
A Phase 2 clinical trial evaluating Proton therapy and Chemotherapy for Anus Neoplasms. Active but no longer recruiting, targeting 14 participants across 1 site.
Detailed Summary
The purpose of this research study is to determine whether the amount of radiation given to the normal areas around the anal cancer can be reduced by using Proton Therapy while reducing the side effects that are seen with standard therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnus Neoplasms
CountriesUnited States
Collaborators--
Timeline
Phase 2ActiveOverdue
2017201820192020202120222023202420252026
Enrollment StartJan 2017
First PostedJan 2017
Primary CompletionApr 2022
Study CompletionJul 2025
TodayJul 2026
First PostedJan 12, 2017
Enrollment StartJan 4, 2017
Primary CompletionApr 7, 2022
Study CompletionJul 1, 2025
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 9.5 years ago
Interventions
Proton therapyradiation
Primary target volume 50.4-54 CGE in 28-30 fractions; Nodal volumes 42-54 CGE in 28-30 fractions
Chemotherapydrug
5FU 1000 mg/m2/day as 96 hour infusion days 1-5 and 29-33; Mitomycin 10mg/m2 days 1 and 29