Infrared Coagulator Ablation or Observation in Preventing Anal Cancer in HIV-Positive Patients With Anal Neoplasia
NCT ID: NCT01164722
Last Updated: 2020-08-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
120 participants
INTERVENTIONAL
2011-04-30
2016-07-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
infrared photocoagulation therapy
Anal infrared coagulator ablation
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.
clinical observation
Patients undergo observation
Interventions
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clinical observation
Patients undergo observation
infrared photocoagulation therapy
Anal infrared coagulator ablation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of high-grade anal intraepithelial neoplasia (AIN) meeting the following:
* AIN2 and/or AIN3 confirmed by biopsy ≥ 2 weeks to ≤ 60 days before enrollment
* 1-3 lesions with each lesion ≤ 15 mm in diameter
* At least one high-grade AIN lesion is still visible at study entry
* HIV-infection documented by federally approved, licensed HIV-test in conjunction with screening test (e.g., ELISA, western blot, or other test)
* HIV-infection, based on prior ELISA and western blot assays, recorded and documented by another physician, allowed provided patient undergoes an approved antibody test to confirm diagnosis
* Patients on concurrent anti-retroviral therapy with a history of HIV-positivity based on an approved antibody test allowed
* Detectable plasma HIV-1 RNA also allowed
* No perianal AIN, perianal condyloma, or lower vulvar intraepithelial neoplasia or condyloma requiring treatment
PATIENT CHARACTERISTICS:
* Karnofsky performance status 70-100%
* Life expectancy ≥ 2 years
* CD4 count ≥ 200/mm³
* ANC \> 750/mm³
* Platelet count ≥ 75,000/mm³
* Hemoglobin ≥ 9.0 g/dL
* INR and aPTT normal
* Negative pregnancy test
* Fertile patients must use effective contraception
* Female patients must have undergone cervical pap smear (if having a cervix) and gynecologic evaluation within the past 12 months
* Must be capable of complying with the requirements of this protocol
* Concurrent HPV-related disease allowed
* No history of anal cancer
* No acute infection or other serious medical illness requiring treatment within the past 14 days
* Fungal infection of the skin or a sexually transmitted disease requiring treatment allowed
* No concurrent malignancy requiring systemic therapy
* Kaposi sarcoma limited to the skin allowed
PRIOR CONCURRENT THERAPY:
* No prior infrared coagulator (IRC) ablation for high-grade anal intraepithelial neoplasia (HGAIN)
* Prior HGAIN treated by any means other than IRC within the past 2 months allowed
* At least 5 days since prior coumadin or clopidogrel and ≥ 7 days after study therapy before receiving coumadin or clopidogrel again
* No concurrent anticoagulant therapy other than aspirin or NSAIDs
* More than 3 months since prior and concurrent systemic corticosteroids, cytokines, or immunomodulatory therapy (e.g., interferons) or local imiquimod
* No concurrent systemic therapy
27 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
The Emmes Company, LLC
INDUSTRY
University of Arkansas
OTHER
AIDS Malignancy Consortium
NETWORK
Responsible Party
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Principal Investigators
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Stephen E. Goldstone, MD
Role: PRINCIPAL_INVESTIGATOR
Laser Surgery Care
Locations
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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
Countries
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References
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Goldstone SE, Lensing SY, Stier EA, Darragh T, Lee JY, van Zante A, Jay N, Berry-Lawhorn JM, Cranston RD, Mitsuyasu R, Aboulafia D, Palefsky JM, Wilkin T. A Randomized Clinical Trial of Infrared Coagulation Ablation Versus Active Monitoring of Intra-anal High-grade Dysplasia in Adults With Human Immunodeficiency Virus Infection: An AIDS Malignancy Consortium Trial. Clin Infect Dis. 2019 Mar 19;68(7):1204-1212. doi: 10.1093/cid/ciy615.
Other Identifiers
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AMC-076
Identifier Type: OTHER
Identifier Source: secondary_id
AMC-076
Identifier Type: -
Identifier Source: org_study_id
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