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Proton Therapy in Reducing Toxicity in Anal Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by University of Cincinnati
Sponsor:
Information provided by (Responsible Party):
Jordan Kharofa, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT03018418
First received: January 10, 2017
Last updated: NA
Last verified: January 2017
History: No changes posted
  Purpose
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.

Condition Intervention Phase
Anus Neoplasms
Radiation: Proton therapy
Drug: Chemotherapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Pilot Study to Evaluate the Feasibility of Intensity Modulated Proton Therapy in Reducing Toxicity in Anal Cancer

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Rates of acute toxicity [ Time Frame: 3 months ]
    Grade 3 or greater hematologic, gastrointestinal, genitourinary, and dermatologic toxicity


Secondary Outcome 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 [ 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


Estimated Enrollment: 20
Study Start Date: January 2017
Estimated Study Completion Date: January 2023
Estimated Primary Completion Date: June 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proton Therapy and Chemotherapy
Standard chemoradiation using 5-FU, Mitomycin, with pencil beam proton radiotherapy
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
Other Names:
  • 5FU
  • Mitomycin

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03018418

Contacts
Contact: UC Cancer Institute Clinical Trials Office 513-584-7698 kastla@ucmail.uc.edu

Locations
United States, Ohio
UC Health Recruiting
Cincinnati, Ohio, United States, 45044
Contact: UCCI Clinical Trials Office    513-584-7698    kastla@ucmail.uc.edu   
Sponsors and Collaborators
Jordan Kharofa
Investigators
Principal Investigator: Jordan Kharofa, MD University of Cincinnati
  More Information

Responsible Party: Jordan Kharofa, Assistant Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT03018418     History of Changes
Other Study ID Numbers: UCCI-GI-16-01
Study First Received: January 10, 2017
Last Updated: January 10, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Cincinnati:
Anal Cancer

Additional relevant MeSH terms:
Anus Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 22, 2017