Infrared Coagulator Ablation or Observation in Preventing Anal Cancer in HIV-Positive Patients Wi… (NCT01164722) | Clinical Trial Compass
CompletedPhase 3
Infrared Coagulator Ablation or Observation in Preventing Anal Cancer in HIV-Positive Patients With Anal Neoplasia
United States120 participantsStarted 2011-04
Plain-language 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.
Who can participate
Age range27 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* 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 cance…