Proton Therapy in Reducing Toxicity in Anal Cancer

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2022

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

Arms, Groups and Cohorts

  • Experimental: Proton Therapy and Chemotherapy
    • Standard chemoradiation using 5-FU, Mitomycin, with pencil beam proton radiotherapy

Clinical Trial Outcome Measures

Primary Measures

  • Rates of acute toxicity
    • Time Frame: 3 months
    • Grade 3 or greater hematologic, gastrointestinal, genitourinary, and dermatologic toxicity

Secondary Measures

  • 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 Changes
    • 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

Participating in This Clinical Trial

Inclusion Criteria

  • Karnofsky Performance Status >70%
  • Histologically documented squamous or basaloid carcinoma of the anal canal
  • Stage T2-4 disease with any N category

Exclusion Criteria

• Patients with a life expectancy of < 3 months.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jordan Kharofa
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Jordan Kharofa, Assistant Professor – University of Cincinnati
  • Overall Official(s)
    • Jordan Kharofa, MD, Principal Investigator, University of Cincinnati
  • Overall Contact(s)
    • UC Cancer Institute Clinical Trials Office, 513-584-7698, cancer@uchealth.com

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