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Surgery in Treating Patients With Early Stage Anal Canal or Perianal Cancer and HIV Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02437851
Recruitment Status : Recruiting
First Posted : May 8, 2015
Last Update Posted : May 9, 2018
National Cancer Institute (NCI)
The Emmes Company, LLC
Information provided by (Responsible Party):
AIDS Malignancy Consortium

Brief Summary:
This phase II trial studies surgery in treating patients with anal canal or perianal cancer that is small and has not spread deeply into the tissues and human immunodeficiency virus (HIV) infection. Local surgery may be a safer treatment with fewer side effects than bigger surgery or radiation and chemotherapy.

Condition or disease Intervention/treatment Phase
Anal Squamous Cell Carcinoma HIV Infection Stage 0 Anal Canal Cancer Stage I Anal Canal Cancer Procedure: Therapeutic Conventional Surgery Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Observational and Feasibility Study of Excision of Superficially Invasive Squamous Cell Carcinoma (SISCCA) of the Anal Canal and Perianus in HIV-Infected Persons
Study Start Date : April 2015
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Treatment (surgery)
Participants undergo therapeutic conventional surgery to remove anal or perianal cancer (SISCCA). Any HSIL remaining is treated with the goal for complete eradication in accordance with clinician and participant preference.
Procedure: Therapeutic Conventional Surgery
Undergo surgery to remove anal or perianal cancer (SISCCA)

Primary Outcome Measures :
  1. The proportion of participants with treatment failure at 2 years will be estimated with the binomial proportion and exact one-sided 95% confidence intervals. [ Time Frame: 2 years after surgery to remove SISCCA ]
    Treatment failure is specifically defined as the occurrence of distant or any nodal metastases or recurrence of cancer that no longer meets the definition of SISCCA and that cannot be excised with a clear margin or preservation of sphincter function and requires CMT, or those who develop SISCCA recurrence but elect to undergo CMT rather than repeat excision in patients originally treated with excision of anal canal and perianal SISCCA.

  2. The proportion of participants with incident SISCCA or anal squamous cancers at sites other than the index SISCCA will be estimated using the binomial proportion and its two-sided exact 95% confidence interval. [ Time Frame: 1 year after surgery to remove SISCCA ]
    Evidence of incident (new) anal squamous cancers or SISCCA at sites other than the index SISCCA treated with surgical excision. The product-limit method will be used to describe the time from treatment enrollment to treatment failure, censoring the time for study participants who do not experience treatment failure.

Secondary Outcome Measures :
  1. The cumulative proportion of study participants who have experienced treatment failure by 3 years will be estimated using the product-limit estimate and its 95% confidence interval using Greenwood's formula. [ Time Frame: 3 years after surgery to remove SISCCA ]
  2. The rate of treatment related adverse events including non-healing ulcer, fissure, persistent pain and bleeding, stricture, incontinence, and colostomy 6 months after excision of SISCCA. [ Time Frame: 6 months after surgery to remove SISCCA ]

Other Outcome Measures:
  1. Collection of clinical specimens (composite) [ Time Frame: Up to 36 months ]
    Clinical specimens, specifically the index SISCCA and the overlying or adjacent HSIL, and HSIL that did not progress to SISCCA and other clinical data will be collected to create a bank of well-annotated specimens that will enable correlative science: to assess viral factors in HSIL progression to cancer and to identify host factors in HSIL progression to cancer.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • A single, biopsy-proven SISCCA as defined by the LAST criteria (=< 3mm depth of invasion, horizontal spread of =< 7 mm, and completely excised with at least 1 mm margin clear of cancer irrespective of the amount of HSIL) documented within 8 weeks of enrollment
  • No evidence of any lymph node spread or distant metastases as determined by positron emission tomography (PET) computed tomography (CT) imaging within 8 weeks of enrollment; alternatively for those without PET CT capability, a magnetic resonance imaging (MRI) or CT of the abdomen and pelvis and a chest x-ray confirming no evidence of metastatic disease is acceptable
  • Clinician believes that eradication of concomitant HSIL is reasonable and feasible based on the extent of disease and overall medical condition of the subject
  • HIV-1 infection, as documented by any federally approved, licensed HIV test performed in conjunction with screening (or enzyme-linked immunosorbent assay [ELISA], test kit, and confirmed by Western blot or other approved test); alternatively, this documentation may include a record demonstrating that another physician has documented the participant's HIV status based on either: 1) approved diagnostic tests or 2) relevant medical history and/or current management of HIV infection
  • Prior to Segment A enrollment, patients on combination anti-retroviral therapy (cART) will be required to have a minimum cluster of differentiation (CD)4 count of >= 200 and patients not on cART will be required to have a minimum CD4 count of >=350 to be eligible for the study; patients not currently on cART who have a CD4 count > 200 and who agree to start cART immediately will be eligible for participation; laboratory data should be obtained within 12 weeks prior to enrollment
  • Participants must have Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Participants must have a life expectancy of 2 years or more
  • Participants must not have any other concurrent malignancy
  • Leukocytes: >= 3,000/mm^3
  • Absolute neutrophil count: >= 1,500/mm^3
  • Platelets: >= 100,000/mm^3
  • Women of childbearing potential must have a negative urine pregnancy test within 72 hours prior to enrollment; female participants are advised to not become pregnant during study participation; all women of childbearing potential must agree to use a reliable birth control method (oral contraceptive pills, intrauterine device, Nexplanon, DepoProvera, or permanent sterilization, etc., or another acceptable method as determined by the investigator) during the entire period of the trial (3 years), and must not intend to become pregnant during study participation and for 3 months after treatment is discontinued
  • Men should not father a child while in this study; men who could father a child must agree to use at least one form of birth control during the study and for 3 months after stopping all study treatment
  • Participants must be able to understand and willing to sign a written informed consent document
  • Participants must, in the opinion of the Investigator, be capable of complying with the requirements of this protocol

Exclusion Criteria:

  • Anal cancer that cannot be completely excised with a >=1 mm clear margin from surrounding tissue or where excision to obtain a clear margin would compromise sphincter function or anal canal diameter
  • Concurrent anal canal or perianal HSIL or condyloma that in the judgment of the clinician cannot be cleared or can only be cleared with undue morbidity to the patient
  • Prior pelvic radiation therapy that would preclude radiation therapy if anal cancer develops
  • Ongoing use of anticoagulant therapy other than aspirin or non-steroidal anti-inflammatory drugs (NSAIDS) that cannot be stopped for surgical procedures
  • Acute treatment for an infection (excluding fungal infection of the skin and sexually transmitted infections) or other serious medical illness within 2 weeks before enrollment
  • Current systemic chemotherapy or radiation therapy that potentially causes bone marrow suppression that would preclude safe treatment of HSIL; Note: Kaposi's sarcoma limited to the skin is not exclusionary unless requiring systemic chemotherapy
  • Prior HPV vaccination
  • Patients who are receiving any other investigational agents within 4 weeks prior to enrollment; investigational antiretroviral agents for HIV are acceptable
  • Participant plans to relocate away from the study site during study participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02437851

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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94115
Contact: Rachel Silverstein    415-353-7443   
Principal Investigator: Michael Berry Lawhorn, MD         
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Elizabeth Stier, MD    617-414-5101   
Principal Investigator: Elizabeth Stier, MD         
United States, New York
Laser Surgery Care Recruiting
New York, New York, United States, 10011
Contact: Stephen E. Goldstone    212-242-6500   
Principal Investigator: Stephen E. Goldstone         
United States, Washington
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98101
Contact: Rachel Dowty    206-342-6928   
Principal Investigator: David Aboulafia, MD         
Sponsors and Collaborators
AIDS Malignancy Consortium
National Cancer Institute (NCI)
The Emmes Company, LLC
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Principal Investigator: Stephen Goldstone AIDS Associated Malignancies Clinical Trials Consortium

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Responsible Party: AIDS Malignancy Consortium Identifier: NCT02437851     History of Changes
Other Study ID Numbers: AMC-092
NCI-2014-02056 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
AMC-092 ( Other Identifier: AIDS - Associated Malignancies Clinical Trials Consortium )
AMC-092 ( Other Identifier: CTEP )
U01CA121947 ( U.S. NIH Grant/Contract )
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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HIV Infections
Acquired Immunodeficiency Syndrome
Carcinoma, Squamous Cell
Anus Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases