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Surgery for Anal Cancer in HIV/AIDS Patients
Phase 2
Waitlist Available
Led By Stephen Goldstone
Research Sponsored by AIDS Malignancy Consortium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No evidence of lymph node spread or distant metastases as determined by PET CT imaging within 16 weeks before enrollment; alternatively, MRI or CT of abdomen and pelvis and chest x-ray confirming no metastatic disease is acceptable for those without PET CT capability
HIV-1 infection documented by licensed HIV screening or HIV-1 RNA detection; specific CD4 count requirements for patients on cART and not on cART
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months after surgery to remove siscca
Awards & highlights
Study Summary
This trial studies surgery to treat patients with early-stage anal cancer and HIV.
Who is the study for?
Adults with early stage anal canal or perianal cancer and HIV can join this trial. They should have a certain level of white blood cells, no history of other cancers, and be able to follow the study plan. Pregnant women can't participate, and men must use birth control if they could father a child.Check my eligibility
What is being tested?
The trial is testing how safe and effective local surgery is for treating small, non-deeply spread anal cancers in patients with HIV. It aims to see if smaller surgeries have fewer side effects compared to larger ones or radiation and chemotherapy.See study design
What are the potential side effects?
Since the intervention involves conventional surgery, potential side effects may include pain at the surgical site, infection risk post-operation, bleeding complications, possible damage to nearby organs or tissues during surgery.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My scans show no cancer spread to lymph nodes or other parts.
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I am HIV positive with specific CD4 count requirements.
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I am able to get out of my bed or chair and move around.
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I do not have any other type of cancer.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months after surgery to remove siscca
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months after surgery to remove siscca
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine if the proportion of participants who develop treatment failure by 3 years is less than 25%.
Secondary outcome measures
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.
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.
Other outcome measures
Collection of clinical specimens (composite)
Side effects data
From 2013 Phase 3 trial • 4312 Patients • NCT0001198697%
Neutropenia
94%
Leukopenia
80%
Anemia
76%
Thrombocytopenia
47%
Gastrointestinal
43%
Constitutional
38%
Other Hemotologic
34%
Pain
17%
Infection/Fever
17%
Peripheral neurologic
17%
Pulmonary
14%
Neurologic
11%
Metabolic
10%
2nd Primary
9%
Hepatic
8%
Dermatologic
7%
Cardiovascular
6%
Allergy
6%
Hemorrhage
5%
Genitourinary/Renal
5%
Musculoskeletal
4%
Ocular/Visual
3%
Endocrine
2%
Auditory
2%
Thrombosis/Embolism
1%
Ileus
1%
Infection Documented W Grd 3/4 Neutropn.
1%
Infection Without Neutropenia
1%
Coagulation
1%
Sexual
1%
Platelets
1%
Allergic Reaction/Hypersensitivity
1%
Febrile Neutropenia-Fuo Infect Not Docum
100%
80%
60%
40%
20%
0%
Study treatment Arm
Carbo/Gemcitabine - Carbo/Taxol
Carbo/Taxol/Gemcitabine
Carbo/Taxol/Doxil
Carbo/Topotecan - Carbo/Taxol
Carbo/Taxol
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (surgery)Experimental Treatment1 Intervention
Participants undergo therapeutic conventional surgery to remove anal or perianal cancer (SISCCA). Any HSIL remaining is treated with the goal for complete eradication in accordance with clinician and participant preference.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9850
Find a Location
Who is running the clinical trial?
The Emmes Company, LLCIndustry Sponsor
145 Previous Clinical Trials
1,051,475 Total Patients Enrolled
AIDS and Cancer Specimen ResourceOTHER
7 Previous Clinical Trials
1,014 Total Patients Enrolled
AIDS Malignancy ConsortiumLead Sponsor
63 Previous Clinical Trials
9,610 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My current cancer treatment is affecting my bone marrow.My SISCCA has not been removed or destroyed.I haven't taken any experimental drugs in the last 4 weeks, except for HIV treatment.I am able to get out of my bed or chair and move around.My biopsy within the last year confirms I have a specific type of cervical condition.My scans show no cancer spread to lymph nodes or other parts.My doctor thinks it's possible to treat my severe precancerous lesions.My anal cancer cannot be fully removed by surgery without affecting my sphincter or narrowing the anal canal.I have severe anal or perianal skin lesions that can't be treated without significant risk.I am HIV positive with specific CD4 count requirements.I do not have any other type of cancer.I am 18 years old or older.I will use birth control during and after the study if I receive topical treatment.I have never had anal cancer or SISCCA.I am on blood thinners that can't be stopped for surgery, except aspirin or NSAIDs.I have not been treated for a serious infection or illness in the last 2 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (surgery)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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