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Anal CancerPhase 3NCT01164722

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

A Phase 3 study testing clinical observation and infrared photocoagulation therapy in people with Anal Cancer and Neoplasm of Uncertain Malignant Potential, run by AIDS Malignancy Consortium at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 27 years and older
What is being tested?
clinical observation and infrared photocoagulation therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
7 sitesUnited States
Study dates
Apr 2011to Jul 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 27 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Boston University Cancer Research Center

    Boston, Massachusetts, 02118

  • UCLA Clinical AIDS Research and Education (CARE) Center

    Los Angeles, California, 90095-1793

  • Laser Surgery Care

    New York, New York, 10010

  • New York Weill Cornell Cancer Center at Cornell University

    New York, New York, 10021

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94143

  • Benaroya Research Institute at Virginia Mason Medical Center

    Seattle, Washington, 98101

Other trials in United States

About this study

Official title: A Randomized Clinical Trial of Infrared Coagulator (IRC) Ablation Versus Expectant Management of Intra-Anal High Grade Intraepithelial Neoplasia (HGAIN) in HIV-infected Adults

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.

Read the 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.

Being tested
clinical observation, infrared photocoagulation therapy
Keywords
anal cancer, HIV infection, human papilloma virus infection, neoplasm of uncertain malignant potential, high-grade squamous intraepithelial lesion
Medical subject headings
Anus Neoplasms, Precancerous Conditions, HIV Infections, Papillomavirus Infections, Squamous Intraepithelial Lesions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • clinical observationOther

    Patients undergo observation

  • infrared photocoagulation therapyDevice

    Also called Redfield Infrared Coagulator, Redfield IRC

    Anal infrared coagulator ablation

Study groups in NCT01164722
Study groupRoleWhat they receive
Arm I: Infrared coagulator treatmentExperimentalInfrared 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.
Receives: Device: infrared photocoagulation therapy
Arm II: Expectant managementActive comparatorPatients 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.
Receives: Other: clinical observation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete Response Through 1 Year

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

    Measured: 1 year post treatment

Secondary outcomes (4)

  1. Tolerability and Safety of Infrared Coagulator Ablation

    Number of patients who experienced a serious adverse events

    Measured: All study visits through year 2

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

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

    Measured: 1 year on study

  3. Recurrence Rate at 1 Year

    Measured: 1 year on study

  4. Incidence of Metachronous Lesions

    Number of patients with one or more metachronous lesions

    Measured: one year on study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2010 (estimated)
  2. Study startApr 2011
  3. Primary completionJul 2015
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01164722
Sponsor's protocol ID
AMC-076
Other IDs
U01CA121947, AMC-076
Status last verified
Jul 2020
First submitted
16 Jul 2010
Last updated
4 Aug 2020
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 30060087

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing clinical observation and infrared photocoagulation therapy in people with Anal Cancer and Neoplasm of Uncertain Malignant Potential, run by AIDS Malignancy Consortium at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Response Through 1 Year (time frame: 1 year post treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01164722, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2020.

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