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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

Must not have

Current systemic chemotherapy or radiation therapy causing bone marrow suppression

SISCCA must not have been ablated

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months after surgery to remove siscca

Awards & highlights

No Placebo-Only Group

Summary

This trial studies surgery to treat patients with small anal or perianal cancer who also have HIV. The surgery aims to safely remove the cancer with fewer side effects compared to other treatments. By cutting out the cancer, it helps prevent it from spreading or returning.

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.

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.

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 below

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My scans show no cancer spread to lymph nodes or other parts.

Select...

I am HIV positive with specific CD4 count requirements.

Select...

I am able to get out of my bed or chair and move around.

Select...

I do not have any other type of cancer.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My current cancer treatment is affecting my bone marrow.

Select...

My SISCCA has not been removed or destroyed.

Select...

My anal cancer cannot be fully removed by surgery without affecting my sphincter or narrowing the anal canal.

Select...

I have severe anal or perianal skin lesions that can't be treated without significant risk.

Select...

I have never had anal cancer or SISCCA.

Select...

I am on blood thinners that can't be stopped for surgery, except aspirin or NSAIDs.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after surgery to remove siscca for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To determine if the proportion of participants who develop treatment failure by 3 years is less than 25%.

Secondary study objectives

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 study objectives

Collection of clinical specimens (composite)

Side effects data

From 2013 Phase 3 trial • 4312 Patients • NCT00011986

95%

Neutropenia

87%

Leukopenia

59%

Anemia

49%

Gastrointestinal

42%

Constitutional

37%

Thrombocytopenia

37%

Pain

24%

Peripheral neurologic

19%

Other Hemotologic

16%

Infection/Fever

14%

Neurologic

14%

Metabolic

12%

Pulmonary

Allergy

2nd Primary

Dermatologic

Musculoskeletal

Cardiovascular

Ocular/Visual

Hepatic

Genitourinary/Renal

Endocrine

Auditory

Hemorrhage

Thrombosis/Embolism

Febrile Neutropenia-Fuo Infect Not Docum

Constipation

Syncope

Vomiting

Abdominal Pain Or Cramping

Infection Documented W Grd 3/4 Neutropn.

Ileus

Coagulation

Allergy-Other

Allergic Reaction/Hypersensitivity

Infection Without Neutropenia

100%

80%

60%

40%

20%

Study treatment Arm

Carbo/Taxol

Carbo/Taxol/Gemcitabine

Carbo/Taxol/Doxil

Carbo/Topotecan - Carbo/Taxol

Carbo/Gemcitabine - Carbo/Taxol

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~9930

0 / 11Eligibility criteria met