Anal Cancer Clinical Trial
Official title:
A Randomized Clinical Trial of Infrared Coagulator (IRC) Ablation Versus Expectant Management of Intra-Anal High Grade Intraepithelial Neoplasia (HGAIN) in HIV-infected Adults
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.
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