Proton Therapy in Reducing Toxicity in Anal Cancer

NCT03018418 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2024-09-19

Study results available
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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.

Conditions

  • Anus Neoplasms

Interventions

RADIATION

Proton therapy

Primary target volume 50.4-54 CGE in 28-30 fractions; Nodal volumes 42-54 CGE in 28-30 fractions

DRUG

Chemotherapy

5FU 1000 mg/m2/day as 96 hour infusion days 1-5 and 29-33; Mitomycin 10mg/m2 days 1 and 29

Sponsors & Collaborators

  • Jordan Kharofa

    lead OTHER

Principal Investigators

  • Jordan Kharofa, MD · University of Cincinnati

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-04
Primary Completion
2022-04-07
Completion
2025-07-01

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03018418 on ClinicalTrials.gov