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Anal Cancer

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.

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.

clinical observation

infrared photocoagulation therapy

Stephen E. Goldstone, MD

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.

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.

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

No detection of high grade anal intraepithelial neoplasia (HGAIN) from treatment through one year. Detection of HGAIN was based on local pathology reports.

Number of patients who experienced a serious adverse events

Number of patients who had high grade anal intraepithelial neoplasia at one year.

Number of patients with one or more metachronous lesions

National Cancer Institute (NCI)

The Emmes Company, LLC

University of Arkansas

AIDS Malignancy Consortium

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.

infrared photocoagulation therapy: Anal infrared coagulator ablation

Arm I: Infrared Coagulator Treatment

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.

clinical observation: Patients undergo observation

Arm II: Expectant Management

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Group Statistician

All study participants who were randomized and attended the baseline visit.

Complete Response Through 1 Year

Tolerability and Safety of Infrared Coagulator Ablation

Patients who had an evaluable biopsy within one year after randomization.

Proportion of Patients With High-grade Anal Intraepithelial Neoplasia at 1 Year

Patients who were treated with IRC, no data were collected on patients on the expectant management arm

Recurrence Rate at 1 Year

Patents with any biopsy from randomization to one year

Incidence of Metachronous Lesions

Overall Study

IRC treatment of up to 3 HGAIN lesions at baseline (study initiation). A second IRC treatment may be administered for recurrent lesions at the 3 month visit.

Infrared Coagulator

Elizabeth Stier, MD

RATIONALE: Infrared coagulation may be effective in preventing the development of anal cancer in patients who have anal neoplasia.

PURPOSE: Pilot study to evaluate the effectiveness of infrared coagulation in preventing anal cancer in HIV-positive patients who have high-grade anal neoplasia.

OBJECTIVES:

* Determine the recurrence rate of high-grade squamous intraepithelial neoplasia in the anal canal of HIV-positive patients treated with infrared coagulation.
* Determine the time to recurrence and time to progression in patients treated with this procedure.
* Determine the toxicity of this procedure in these patients.
* Correlate CD4/CD8 count and HIV viral load with outcome in patients treated with this procedure.
* Correlate outcome with human papilloma virus subtype in patients treated with this procedure.

OUTLINE: This is an open-label, pilot, multicenter study.

Patients undergo treatment with an infrared coagulator in direct contact with the lesion for 1.5 seconds and necrotic tissue is then debrided. Treatment repeats to the level of the submucosal vessels under colposcopic guidance. A repeat biopsy is performed at 3 months to assess treatment success. Patients with incompletely treated lesions receive 1 more treatment. Up to 3 lesions are treated during each visit in the absence of disease progression or unacceptable toxicity.

Patients complete questionnaires regarding anal pain and discomfort at baseline, at 4 weeks, and at 3, 6, 9, and 12 months.

Patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study within 6 months.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Infrared Coagulator Ablation or Observation in Preventing Anal Cancer in HIV-Positive Patients With Anal Neoplasia	NCT01164722	Anal Cancer Neoplasm of Unc... Nonneoplastic C... Precancerous Co...	clinical observ... infrared photoc...	27 Years -	AIDS Malignancy Consortium
Infrared Coagulation in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia	NCT00066430	Anal Cancer Precancerous Co...	infrared photoc... Infrared Coagul...	18 Years -	AIDS Malignancy Consortium
Infrared Coagulator Ablation or Observation in Preventing Anal Cancer in HIV-Positive Patients With Anal Neoplasia	NCT01164722	Anal Cancer Neoplasm of Unc... Nonneoplastic C... Precancerous Co...	clinical observ... infrared photoc...	27 Years -	AIDS Malignancy Consortium
Infrared Coagulation in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia	NCT00066430	Anal Cancer Precancerous Co...	infrared photoc... Infrared Coagul...	18 Years -	AIDS Malignancy Consortium
Infrared Coagulator Ablation or Observation in Preventing Anal Cancer in HIV-Positive Patients With Anal Neoplasia	NCT01164722	Anal Cancer Neoplasm of Unc... Nonneoplastic C... Precancerous Co...	clinical observ... infrared photoc...	27 Years -	AIDS Malignancy Consortium

Spots Global Cancer Trial Database for infrared photocoagulation therapy