NCT01164722

Infrared Coagulator Ablation or Observation in Preventing Anal Cancer in HIV-Positive Patients With Anal Neoplasia

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: AIDS Malignancy Consortium · Network
• Sex: All
• Age: 27 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Anal Cancer
• Neoplasm of Uncertain Malignant Potential
• Nonneoplastic Condition
• Precancerous Condition

Interventions

Type	Name	Description
OTHER	clinical observation	Patients undergo observation
DEVICE	infrared photocoagulation therapy	Anal infrared coagulator ablation

Timeline

• Start date: 2011-04-01
• Primary completion: 2015-07-01
• Completion: 2016-07-01
• First posted: 2010-07-19
• Last updated: 2020-08-04
• Results posted: 2016-10-31

Locations

7 sites across 1 country: United States