Surgery in Treating Patients with Early Stage Anal Canal or Perianal Cancer and HIV Positive

Active:	No
Cancer Type:	Anal Cancer	NCT ID:	NCT02437851
Trial Phases:	Phase II	Protocol IDs:	AMC-092 (primary) AMC-092 NCI-2014-02056 092 AMC #092
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	AIDS Malignancy Consortium
NCI Full Details:	http://clinicaltrials.gov/show/NCT02437851

Summary

This phase II trial studies how well surgery works 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) positive. Local surgery may be a safer treatment with fewer side effects than bigger surgery or radiation and chemotherapy.

Objectives

PRIMARY OBJECTIVE:
I. To determine if the proportion of participants who develop treatment failure by 3 years is less than 25%, defined as the occurrence of distant or any nodal metastases or recurrence of cancer requiring combined modality therapy (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 participants originally treated with excision of anal canal and perianal SISCCA

SECONDARY OBJECTIVE:
I. To determine morbidities associated with local excision of SISCCA and treatment of concomitant HSIL, including non-healing ulcer, fissure, persistent pain and bleeding, stricture, incontinence, and colostomy at 3 years after enrollment.

EXPLORATORY OBJECTIVES:
I. To assess viral factors in high grade squamous intraepithelial neoplasia (HSIL) progression to cancer:
Ia. To determine the human papillomavirus (HPV) type in cancer and compare to that of overlying HSIL and HSIL biopsies collected concurrently that did not progress to cancer.
Ib. 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.
II. To identify host factors in HSIL progression to cancer:
IIa. Perform gene expression array analysis comparing expression in anal cancer with HSIL overlying or contiguous with the cancer.
IIb. Perform gene expression array analysis comparing expression in HSIL biopsies that progressed to cancer with non-progressing HSIL biopsies at other locations.
IIc. Characterize genetic changes in anal cancers compared with HSIL overlying or contiguous with the cancer.
IId. Characterize genetic changes in HSIL biopsies that progressed to cancer compared with non-progressing HSIL biopsies at other locations.
IIe. 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.

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