NCT01164722已完成3 期
A Randomized Clinical Trial of Infrared Coagulator (IRC) Ablation Versus Expectant Management of Intra-Anal High Grade Intraepithelial Neoplasia (HGAIN) in HIV-infected Adults
AIDS Malignancy Consortium12 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2011年4月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 12
- 主要终点
- Complete Response Through 1 Year
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 27 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 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
排除标准
- 未提供
结局指标
主要结局
Complete Response Through 1 Year
时间窗: 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.
次要结局
- Recurrence Rate at 1 Year(1 year on study)
- Incidence of Metachronous Lesions(one year on study)
- Tolerability and Safety of Infrared Coagulator Ablation(All study visits through year 2)
- Proportion of Patients With High-grade Anal Intraepithelial Neoplasia at 1 Year(1 year on study)
研究者
研究点 (12)
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