RATIONALE: Infrared coagulator ablation may be effective in preventing the development of anal cancer in patients with anal neoplasia PURPOSE: This randomized phase III trial is studying infrared coagulator ablation to see how well it works compared to observation in preventing anal cancer in HIV-positive patients with anal neoplasia.
OBJECTIVES: Primary * Evaluate the complete response rate at 3 months and 1 year in HIV-seropositive patients with high-grade anal intraepithelial neoplasia (HGAIN) treated with infrared coagulator (IRC) ablation versus observation. Secondary * Determine the tolerability and safety of IRC ablation versus observation in these patients. * Compare the proportion of patients with HGAIN at 1 year. * Evaluate the response and recurrence rates at 1 year of individual lesions in patients treated with this regimen vs observation. * Determine the incidence of metachronous lesions in these patients. * Compare the response and recurrence rates at 2 years of individual lesions in patients under observation who subsequently received IRC ablation with the response and recurrence rates at 1 year in patients initially treated with IRC. OUTLINE: This is a multicenter study. Patients are stratified according to site. Patients are randomized to 1 of 2 arms. * Arm I: Infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance for 1.5 seconds. IRC ablation is reapplied until the level of submucosal vessels are reached. * One week after each IRC ablation, patients complete a questionnaire regarding pain, bleeding, and other complaints. * Arm II: Patients receive standard of care and undergo observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions. NOTE: Patients may receive a maximum of 6 IRC treatments while on study (3 per year). Patients undergo a physical exam, digital rectal exam, anal cytology, and HRA at baseline and periodically during study. After completion of study therapy, patients are followed up periodically for 2 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
120
Patients undergo observation
Anal infrared coagulator ablation
UCLA Clinical AIDS Research and Education (CARE) Center
Los Angeles, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Boston University Cancer Research Center
Boston, Massachusetts, United States
Laser Surgery Care
New York, New York, United States
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Benaroya Research Institute at Virginia Mason Medical Center
Seattle, Washington, United States
Complete Response Through 1 Year
No detection of high grade anal intraepithelial neoplasia (HGAIN) from treatment through one year. Detection of HGAIN was based on local pathology reports.
Time frame: 1 year post treatment
Tolerability and Safety of Infrared Coagulator Ablation
Number of patients who experienced a serious adverse events
Time frame: All study visits through year 2
Proportion of Patients With High-grade Anal Intraepithelial Neoplasia at 1 Year
Number of patients who had high grade anal intraepithelial neoplasia at one year.
Time frame: 1 year on study
Recurrence Rate at 1 Year
Time frame: 1 year on study
Incidence of Metachronous Lesions
Number of patients with one or more metachronous lesions
Time frame: one year on study
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