Infrared Coagulator Ablation or Observation in Preventing Anal Cancer in HIV-Positive Patients With Anal Neoplasia
|ClinicalTrials.gov Identifier: NCT01164722|
Recruitment Status : Completed
First Posted : July 19, 2010
Results First Posted : October 31, 2016
Last Update Posted : February 13, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Anal Cancer Neoplasm of Uncertain Malignant Potential Nonneoplastic Condition Precancerous Condition||Other: clinical observation Device: infrared photocoagulation therapy||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2016|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|