A Randomized Clinical Trial of Infrared Coagulator (IRC) Ablation Versus Expectant Management of Intra-Anal High Grade Intraepithelial Neoplasia (HGAIN) in HIV-infected Adults
- 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.
- Determine the tolerability and safety of IRC ablation versus observation in these
- 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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
Complete response at 3 months and 1 year
3 months and 1 year post treatment
Stephen E. Goldstone, MD
Laser Surgery Care
United States: Federal Government
|New York Weill Cornell Cancer Center at Cornell University||New York, New York 10021|
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|
|University of Pittsburgh Medical Center||Pittsburgh, Pennsylvania 15213|
|UCLA Clinical AIDS Research and Education (CARE) Center||Los Angeles, California 90024|
|Boston University Cancer Research Center||Boston, Massachusetts 02118|
|Laser Surgery Care||New York, New York 10011|