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

Phase 3

Completed

• Conditions: Anal Cancer; Neoplasm of Uncertain Malignant Potential; Precancerous Condition; Nonneoplastic Condition

• Registration Number: NCT01164722
• Lead Sponsor: AIDS Malignancy Consortium

Brief 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.

Study Timeline

• Study First Submitted: 2010-07-16
• Study First Submitted QC: 2010-07-16
• Study First Posted: 2010-07-19
• Study Start: 2011-04
• Primary Completion: 2015-07
• Study Completion: 2016-07
• Results First Submitted: 2016-09-09
• Results First Submitted QC: 2016-09-09
• Results First Posted: 2016-10-31
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-28
• Last Update Posted: 2020-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Complete Response Through 1 Year	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.

Secondary Outcome Measures

Name	Time	Method
Recurrence Rate at 1 Year	1 year on study
Incidence of Metachronous Lesions	one year on study	Number of patients with one or more metachronous lesions
Tolerability and Safety of Infrared Coagulator Ablation	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	1 year on study	Number of patients who had high grade anal intraepithelial neoplasia at one year.

Trial Locations

Locations (7)

UCLA Clinical AIDS Research and Education (CARE) Center; 🇺🇸 Los Angeles, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center; 🇺🇸 San Francisco, California, United States

Boston University Cancer Research Center; 🇺🇸 Boston, Massachusetts, United States

Laser Surgery Care; 🇺🇸 New York, New York, United States

New York Weill Cornell Cancer Center at Cornell University; 🇺🇸 New York, New York, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Benaroya Research Institute at Virginia Mason Medical Center; 🇺🇸 Seattle, Washington, United States