Surgery in Treating Patients With Early Stage Anal Canal or Perianal Cancer and HIV Infection (NCT02437851) | Clinical Trial Compass
CompletedPhase 2
Surgery in Treating Patients With Early Stage Anal Canal or Perianal Cancer and HIV Infection
United States16 participantsStarted 2015-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 per investigator assessment in combination with the pathology report within 12 months before Segment B enrollment.
* No evidence of any lymph node spread or distant metastases as determined by PET CT imaging within 16 weeks before Segment B enrollment. Alternatively, for those without PET CT capability, an 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 one of the following: licensed HIV screening (antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody differentiation assay, Documentation of HIV diagnosis in the medical record by a licensed HIV rapid test health care provider, HIV-1 RNA detection by a licensed HIV-1 RNA assay demonstrating \>1000 RNA copies/mL, or Documentation of receipt of ART by a licensed health care provider.
* Prior to Segment B enrollment, patients on combination anti-retroviral therapy (cART) will be required to have a minimum c…
What they're measuring
1
To determine if the proportion of participants who develop treatment failure by 3 years is less than 25%.