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Chemotherapy

Chemotherapy + Radiation for HIV-Associated Anal Cancer

Q: What cancerous growths does Intensity-Modulated Radiation Therapy target?

Intensity-Modulated Radiation Therapy is a type of <a href="https://www.withpower.com/clinical-trials/cancer">cancer</a> treatment that uses high energy x-rays to kill cancer cells. This modality can also be used to treat other conditions, like unresectable <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>, <a href="https://www.withpower.com/clinical-trials/squamous-cell-carcinoma">squamous cell carcinoma</a>, and <a href="https://www.withpower.com/clinical-trials/glaucoma">glaucoma</a>.

Q: Is Intensity-Modulated Radiation Therapy a danger to human subjects?

Intensity-Modulated Radiation Therapy has been evaluated for safety in a Phase 2 trial, meaning that there is some data to support its safety but not its efficacy. Our team at Power rates it as a 2 on our scale.

Q: Is this research project taking place in more than one facility within the city limits?

The trial is being conducted by the <a href="https://www.withpower.com/clinical-trials/aids">AIDS</a> Malignancy Consortium out of Rockville, <a href="https://www.withpower.com/clinical-trials/maryland">Maryland</a> as well as Montefiore Medical Center in Bronx, <a href="https://www.withpower.com/clinical-trials/new-york">New york</a> and <a href="https://www.withpower.com/clinical-trials/washington">Washington</a>, District of Columbia. There are also 8 other satellite locations.

Q: How many research participants will this study be able to accommodate?

This study requires 53 individuals that fit the pre-determined eligibility criteria. Those interested in participating can do so at clinics such as <a href="https://www.withpower.com/clinical-trials/aids">AIDS</a> Malignancy Consortium or Montefiore Medical Center-Einstein Campus.

Q: Are there more examples of cancer patients being treated with Intensity-Modulated Radiation Therapy?

There are a total of 1373 ongoing Intensity-Modulated Radiation Therapy studies, with 295 in the critical third phase. Many of these trials originate in Guangzhou, Guangdong; however, there are65656 locations around the world where patients can access this treatment.

Q: What are we hoping to learn from this research?

The primary goal for this trial, which will take place over the course of 5 years, is to evaluate the incidence of adverse events in high-risk patients. Additionally, disease-free survival rate and cumulative incidence of pelvic disease relapse will be monitored in high-risk patients using Kaplan-Meier methodologies. Statistical significance will be set at a p-value of 0.05. Furthermore, changes in cART adherence and <a href="https://www.withpower.com/clinical-trials/hiv">HIV</a> viral load before, during, and after treatment will also be assessed in low-risk patients to identify any potential barriers to care.

Q: Are new participants currently being accepted for this clinical trial?

This trial, which is currently recruiting participants, was first posted on 11/23/2021 and last updated on 10/21/2022.

Phase 2

Recruiting

Led By Rafi Kabarriti

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant must have =< grade 2 diarrhea

Participant must have histologically proven stage (T3-T4N0M0 OR T2-4N1M0) invasive squamous cell carcinoma (SCC) of the anus or anorectum as documented before CRT initiation, according to the American Joint Committee on Cancer (AJCC) 8th edition. Participants with squamous cell carcinoma of the anal margin are eligible if there is evidence of extension of the primary tumor into the anal canal. Participants with tumors of non-keratinizing histology such as basaloid, transitional cell or cloacogenic histology are permitted

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is studying patients with low-risk or high-risk HIV-associated anal cancer to see if giving chemotherapy and radiation therapy with or without nivolumab may help to control the cancer.

Who is the study for?

This trial is for adults with HIV-associated anal cancer. Low-risk patients have T1-2N0M0 tumors ≤4 cm, while high-risk patients have stage T3-T4N0M0 or T2-4N1M0 tumors. All must understand the study, sign consent, have a life expectancy over 6 months, adequate blood counts and organ function, be on stable HIV treatment with controlled viral load, agree to contraception if applicable, and not be pregnant or breastfeeding.Check my eligibility

What is being tested?

The trial tests chemotherapy (mitomycin, fluorouracil/capecitabine) combined with intensity-modulated radiation therapy for low-risk anal cancer patients. High-risk patients receive standard care plus nivolumab post-treatment to reduce tumor recurrence risk. Nivolumab is an immunotherapy that may help the immune system fight cancer more effectively.See study design

What are the potential side effects?

Chemotherapy can cause nausea, fatigue, hair loss and increased infection risk. Radiation might lead to skin irritation and fatigue. Nivolumab could result in immune-related side effects like inflammation of organs such as lungs or intestines and potential infusion reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My diarrhea is mild or moderate.

Select...

I have a specific type of anal cancer that is at a certain stage and has not spread to distant parts of my body.

Select...

I can take care of myself but might not be able to do heavy physical work.

Select...

I am on a consistent HIV medication regimen.

Select...

I have received radiation therapy for anal cancer.

Select...

I am 18 years old or older.

Select...

I have tested negative for tuberculosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events (High-risk stratum)

Incidence of adverse events (Low-risk stratum)

Secondary outcome measures

Change in CD4+ cell counts (High-risk stratum)

Change in combination antiretroviral therapy (cART) adherence

Change in human immunodeficiency virus (HIV) viral load (Low-risk stratum)

+2 more

Other outcome measures

Effect of reduced intensity CRT and nivolumab on viral HIV reservoirs

Impact of reduced intensity CRT on quality of life

Prevalence of cell-free plasma HPV deoxyribonucleic acid (DNA) before and after reduced intensity CRT and nivolumab

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Low-risk stratum (mitomycinExperimental Treatment4 Interventions

Patients receive mitomycin IV on day 1 and either fluorouracil IV on day 1 or capecitabine PO BID on Monday-Friday until the completion of radiation therapy at the discretion of the treating physician. Patients also undergo IMRT QD for 20-23 treatment sessions over 6 weeks.

Group II: High-risk stratum (nivolumab)Experimental Treatment1 Intervention

Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 4 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2014

Completed Phase 3

~4750

Mitomycin

2009

Completed Phase 3

~410

Capecitabine

2013

Completed Phase 3

~3420

Fluorouracil

2014

Completed Phase 3

~11540

Intensity-Modulated Radiation Therapy

2010

Completed Phase 3

~2160

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,665 Previous Clinical Trials

40,925,801 Total Patients Enrolled

Rafi KabarritiPrincipal InvestigatorAIDS Malignancy Consortium

Media Library

Capecitabine (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04929028 — Phase 2

Anal Carcinoma Research Study Groups: High-risk stratum (nivolumab), Low-risk stratum (mitomycin

Anal Carcinoma Clinical Trial 2023: Capecitabine Highlights & Side Effects. Trial Name: NCT04929028 — Phase 2

Capecitabine (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04929028 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What cancerous growths does Intensity-Modulated Radiation Therapy target?

"Intensity-Modulated Radiation Therapy is a type of cancer treatment that uses high energy x-rays to kill cancer cells. This modality can also be used to treat other conditions, like unresectable melanoma, squamous cell carcinoma, and glaucoma."

Answered by AI

Is Intensity-Modulated Radiation Therapy a danger to human subjects?

"Intensity-Modulated Radiation Therapy has been evaluated for safety in a Phase 2 trial, meaning that there is some data to support its safety but not its efficacy. Our team at Power rates it as a 2 on our scale."

Answered by AI

Is this research project taking place in more than one facility within the city limits?

"The trial is being conducted by the AIDS Malignancy Consortium out of Rockville, Maryland as well as Montefiore Medical Center in Bronx, New york and Washington, District of Columbia. There are also 8 other satellite locations."

Answered by AI

How many research participants will this study be able to accommodate?

"This study requires 53 individuals that fit the pre-determined eligibility criteria. Those interested in participating can do so at clinics such as AIDS Malignancy Consortium or Montefiore Medical Center-Einstein Campus."

Answered by AI

Are there more examples of cancer patients being treated with Intensity-Modulated Radiation Therapy?

"There are a total of 1373 ongoing Intensity-Modulated Radiation Therapy studies, with 295 in the critical third phase. Many of these trials originate in Guangzhou, Guangdong; however, there are65656 locations around the world where patients can access this treatment."

Answered by AI

What are we hoping to learn from this research?

"The primary goal for this trial, which will take place over the course of 5 years, is to evaluate the incidence of adverse events in high-risk patients. Additionally, disease-free survival rate and cumulative incidence of pelvic disease relapse will be monitored in high-risk patients using Kaplan-Meier methodologies. Statistical significance will be set at a p-value of 0.05. Furthermore, changes in cART adherence and HIV viral load before, during, and after treatment will also be assessed in low-risk patients to identify any potential barriers to care."

Answered by AI