Therapeutic Conventional Surgery for Anal Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Montefiore Medical Center, Bronx, NYAnal Carcinoma+3 MoreTherapeutic Conventional Surgery - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

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

2 of 3
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.
This histogram enumerates side effects from a completed 2013 Phase 3 trial (NCT00011986) in the Carbo/Topotecan - Carbo/Taxol ARM group. Side effects include: Neutropenia with 98%, Leukopenia with 92%, Anemia with 76%, Thrombocytopenia with 54%, Gastrointestinal with 48%.

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: Procedure
Treatment
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

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.