Surgery for Treating Early Stage Anal or Perianal Cancer in Patients with HIV

Sponsor: AIDS Malignancy Consortium

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02437851

Provider View

This study is exploring the use of surgery to treat small, early-stage anal or perianal cancer in patients who also have HIV. The goal is to see if local surgery can be a safer option with fewer side effects compared to more extensive surgery or treatments like radiation and chemotherapy.

Patient Parameters

Program Overview

This phase II clinical trial is investigating whether surgery can effectively treat small anal or perianal cancers in patients with HIV. The study focuses on cancers that have not spread deeply into the tissues. Researchers aim to determine if local surgery can be a safer treatment option with fewer side effects than more extensive surgery or other treatments like radiation and chemotherapy.

Description

The main goal of this study is to see if less than 25% of participants experience treatment failure within three years. Treatment failure is defined as cancer spreading to other areas, returning in a way that requires chemotherapy, or not being completely removed with surgery. The study also aims to see if new anal cancers develop in different areas within one year after surgery.

Secondary goals include evaluating any complications from the surgery, such as non-healing wounds, pain, bleeding, or incontinence, within three years.

Exploratory goals involve studying the types of human papillomavirus (HPV) present in the cancer and comparing them to other lesions that did not progress to cancer. Researchers will also analyze genetic changes in the cancer and surrounding tissues.

Participants will undergo surgery to remove the cancer, and any remaining high-grade lesions will be treated according to the patient's and doctor's preferences. After treatment, participants will have follow-up visits every three months for three years.

Eligibility Criteria

Inclusion Criteria

  • Have a single, small anal or perianal cancer that has been confirmed by a biopsy and meets specific size criteria.
  • No evidence of cancer spread to lymph nodes or other parts of the body, confirmed by imaging tests.
  • The doctor believes that any remaining high-grade lesions can be treated effectively.
  • Have HIV infection, confirmed by specific tests or medical records.
  • Meet certain immune system criteria based on CD4 count, with adjustments for those on or not on HIV medication.
  • Have a performance status score of 0 to 2, indicating good overall health.
  • Have a life expectancy of at least two years.
  • No other active cancers.
  • Be 18 years or older.
  • Meet specific blood count and organ function criteria.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for three months after treatment.
  • Men must agree to use birth control or abstain from fathering a child during the study and for two weeks after treatment.
  • Be able to understand and sign a consent form.
  • Be able to comply with the study requirements.

Exclusion Criteria

  • Cancer that cannot be completely removed with surgery without affecting anal function.
  • Other anal conditions that cannot be treated without significant risk.
  • Previous history of anal cancer.
  • Use of certain blood thinners that cannot be stopped for surgery.
  • Recent treatment for a serious infection or illness.
  • Current chemotherapy or radiation that affects bone marrow.
  • Cancer that has been treated with ablation.
  • Participation in another clinical trial within four weeks before joining this study, except for certain HIV medications.
  • Plans to move away from the study site during participation.

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