Study Summary
This trial studies surgery to treat patients with early-stage anal cancer and HIV.
Eligible Conditions
- Squamous Cell Anal Carcinoma
- Stage I Anal Cancer
- Stage 0 Anal Canal Cancer
- HIV/AIDS
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 2 Secondary · Reporting Duration: 6 months after surgery to remove SISCCA
Year 1
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.
Year 2
The proportion of participants with treatment failure at 2 years will be estimated with the binomial proportion and exact one-sided 95% confidence intervals.
Year 3
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.
To determine if the proportion of participants who develop treatment failure by 3 years is less than 25%.
Month 6
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.
Up to 36 months
Collection of clinical specimens (composite)
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
Carbo/Topotecan - Carbo/Taxol
98%Neutropenia
92%Leukopenia
76%Anemia
54%Thrombocytopenia
48%Gastrointestinal
43%Constitutional
35%Pain
31%Other Hemotologic
17%Infection/Fever
16%Peripheral neurologic
13%Pulmonary
11%Neurologic
9%Metabolic
9%2nd Primary
6%Dermatologic
5%Endocrine
5%Allergy
5%Hepatic
5%Musculoskeletal
4%Cardiovascular
4%Genitourinary/Renal
3%Ocular/Visual
2%Auditory
2%Hemorrhage
2%Thrombosis/Embolism
2%Coagulation
1%Febrile Neutropenia-Fuo Infect Not Docum
1%Sexual
1%Constipation
1%Infection Without Neutropenia
1%Ileus
1%Vomiting
1%Infection Documented W Grd 3/4 Neutropn.
Trial Design
1 Treatment Group
Treatment (surgery)
1 of 1
Experimental Treatment
20 Total Participants · 1 Treatment Group
Primary Treatment: Therapeutic Conventional Surgery · No Placebo Group · Phase 2
Treatment (surgery)
Procedure
Experimental Group · 1 Intervention: Therapeutic Conventional Surgery · Intervention Types: ProcedureTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Therapeutic Conventional Surgery
2005
Completed Phase 3
~8410
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months after surgery to remove siscca
Who is running the clinical trial?
University of ArkansasOTHER
466 Previous Clinical Trials
147,520 Total Patients Enrolled
AIDS and Cancer Specimen ResourceOTHER
7 Previous Clinical Trials
1,014 Total Patients Enrolled
AIDS Malignancy ConsortiumLead Sponsor
62 Previous Clinical Trials
9,652 Total Patients Enrolled
The Emmes Company, LLCIndustry Sponsor
138 Previous Clinical Trials
1,050,823 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,156 Previous Clinical Trials
41,163,580 Total Patients Enrolled
Stephen GoldstonePrincipal InvestigatorAIDS Associated Malignancies Clinical Trials Consortium
Eligibility Criteria
Age 18+ · All Participants · 16 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Your doctor thinks it's possible to cure any high-grade abnormal cells in addition to your current condition based on how widespread they are and your overall health.
You cannot have any other type of cancer at the same time.
References
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Frequently Asked Questions
What is the size of this medical study's participant base?
"The Emmes Company, LLC is supervising this trial from multiple locations including Boston Medical Center in Massachusetts and University of California, San Francisco in Cali. In order to execute the study 20 patients that meet all predetermined inclusion criteria are needed." - Anonymous Online Contributor
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Has the FDA accepted Therapeutic Conventional Surgery as a legitimate therapeutic option?
"Our team at Power estimated the safety of Therapeutic Conventional Surgery to be a 2 based on existing evidence. As this is currently in Phase 2, there are some data points attesting to its relative security but no studies demonstrating efficacy." - Anonymous Online Contributor
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Is this research program still recruiting participants?
"Upon review of the details provided on clinicaltrials.gov, it is evident that this medical trial has been recruiting patients since April 1st 2015 and that its parameters have recently been updated on September 20th 2022." - Anonymous Online Contributor
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How far-reaching is this medical experiment with regard to geographical locale?
"This clinical trial is currently operating at 5 different sites, three of which can be found in Boston, San Francisco and the Bronx. There are also 2 additional locations offering this medication." - Anonymous Online Contributor
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