Infrared Coagulator Ablation or Observation in Preventing Anal Cancer in HIV-Positive Patients With Anal Neoplasia
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.
|Anal Cancer Neoplasm of Uncertain Malignant Potential Nonneoplastic Condition Precancerous Condition||Other: clinical observation Device: infrared photocoagulation therapy||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|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|
- Complete Response Through 1 Year [ Time Frame: 1 year post treatment ]No detection of high grade anal intraepithelial neoplasia (HGAIN) from treatment through one year. Detection of HGAIN was based on local pathology reports.
- Tolerability and Safety of Infrared Coagulator Ablation [ Time Frame: All study visits through year 2 ]Number of patients who experienced a serious adverse events
- Proportion of Patients With High-grade Anal Intraepithelial Neoplasia at 1 Year [ Time Frame: 1 year on study ]Number of patients who had high grade anal intraepithelial neoplasia at one year.
- Recurrence Rate at 1 Year [ Time Frame: 1 year on study ]
- Incidence of Metachronous Lesions [ Time Frame: one year on study ]Number of patients with one or more metachronous lesions
|Study Start Date:||April 2011|
|Study Completion Date:||July 2016|
|Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Experimental: Arm I: Infrared coagulator treatment
Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.
Device: infrared photocoagulation therapy
Anal infrared coagulator ablation
Active Comparator: Arm II: Expectant management
Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.
Other: clinical observation
Patients undergo observation
- 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01164722
|United States, California|
|UCLA Clinical AIDS Research and Education (CARE) Center|
|Los Angeles, California, United States, 90095-1793|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94143|
|United States, Massachusetts|
|Boston University Cancer Research Center|
|Boston, Massachusetts, United States, 02118|
|United States, New York|
|Laser Surgery Care|
|New York, New York, United States, 10010|
|New York Weill Cornell Cancer Center at Cornell University|
|New York, New York, United States, 10021|
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Washington|
|Benaroya Research Institute at Virginia Mason Medical Center|
|Seattle, Washington, United States, 98101|
|Principal Investigator:||Stephen E. Goldstone, MD||Laser Surgery Care|