Clinical Trial: Proton Therapy in Reducing Toxicity in Anal Cancer

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Prospective Pilot Study to Evaluate the Feasibility of Intensity Modulated Proton Therapy in Reducing Toxicity in Anal Cancer

Brief 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.

Detailed Summary:
Sponsor: Jordan Kharofa

Current Primary Outcome: Rates of acute toxicity [ Time Frame: 3 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Rates of late toxicity [ Time Frame: every 6 months up to 60 months ]
  Grade 3 or greater hematologic, gastrointestinal, genitourinary, and dermatologic toxicity
• Complete response rate [ Time Frame: every 6 months up to 60 months ]
  clinical complete response
• Local progression free survival [ Time Frame: every 6 months up to 60 months ]
  time from the date of registration to the date of the first documented locoregional recurrence
• Overall survival [ Time Frame: every 6 months up to 60 months ]
  time from the date of registration to the date of death due to all causes
• Distant metastases free survival [ Time Frame: every 6 months up to 60 months ]
  time from the date of registration to the date of first documented distant recurrence
• Quality of Life [ Time Frame: before and after treatment up to 12 months ]
  Utilization of the Patient Reported Outcomes- Common Toxicity Criteria for Adverse Events at pretreatment, 2 weeks, 4 weeks, 3, 6, and 12 months

Original Secondary Outcome: Same as current

Information By: University of Cincinnati

Dates:
Date Received: January 10, 2017
Date Started: January 2017
Date Completion: January 2023
Last Updated: January 10, 2017
Last Verified: January 2017