Last updated on May 2018

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


Brief description of study

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.

Detailed Study Description

PRIMARY OBJECTIVES:

I. To define the proportion of participants who develop treatment failure at 2 years, defined as the occurrence of distant or any nodal metastases or recurrence of cancer requiring chemotherapy (CMT), defined as a cancer that no longer meets the definition of superficially invasive squamous cell carcinoma (SISCCA) or a cancer that cannot be excised with a clear margin or preservation of sphincter function, 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.

II. To define the 1-year proportion of participants who develop incident anal squamous cancers at sites other than the location of the index SISCCA in patients treated with excision of anal canal and perianal SISCCA.

SECONDARY OBJECTIVES:

I. To define the proportion of participants who develop treatment failure at 3 years, defined as occurrence of distant or any nodal metastases or recurrence of cancer requiring CMT, defined as a cancer that no longer meets the definition of SISCCA or a cancer that cannot be excised with a clear margin or preservation of sphincter function or those who develop SISCCA recurrence but elect to undergo CMT rather than repeat excision in patients treated with excision of anal canal and perianal SISCCA.

II. To determine morbidities associated with local excision of SISCCA, including non-healing ulcer, fissure, persistent pain and bleeding, stricture, incontinence, and colostomy 6 months after excision of SISCCA.

EXPLORATORY OBJECTIVES:

I. To determine the human papillomavirus (HPV) type in cancer and compare to that of overlying high-grade squamous intraepithelial lesions (HSIL) and HSIL biopsies collected concurrently that did not progress to cancer.

II. To determine and compare the HPV integration site in the anal cancer as well as in HSIL overlying or contiguous with the cancer and HSIL biopsies collected concurrently that did not progress to cancer.

III. Perform gene expression array analysis comparing expression in anal cancer with HSIL overlying or contiguous with the cancer.

IV. Perform gene expression array analysis comparing expression in HSIL biopsies that progressed to cancer with non-progressing HSIL biopsies at other locations.

V. Characterize genetic changes in anal cancers compared with HSIL overlying or contiguous with the cancer.

VI. Characterize genetic changes in HSIL biopsies that progressed to cancer compared with non-progressing HSIL biopsies at other locations.

VII. Perform gene expression array analysis and characterize genetic changes of SISCCAs that were cured with wide local excision for comparison with SISCCAs that progressed after wide local excision.

OUTLINE

Patients undergo surgery to remove anal or perianal cancer. Any HSIL remaining is treated with the goal for complete eradication in accordance with clinician and participant preference.

After completion of study treatment, patients are followed up every 3 months for 36 months.

Clinical Study Identifier: NCT02437851

Contact Investigators or Research Sites near you

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Michael Berry Lawhorn, MD

University of California, San Francisco
San Francisco, CA United States
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Elizabeth Stier, MD

Boston Medical Center
Boston, MA United States
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Stephen E. Goldstone

Laser Surgery Care
New York, NY United States
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David Aboulafia, MD

Virginia Mason Medical Center
Seattle, WA United States
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Recruitment Status: Open


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