What side effects are associated with this type of intervention?

Common treatments for anal cancer include radiation therapy, chemotherapy, and surgery. Radiation therapy, which is often used in combination with chemotherapy, can lead to side effects such as skin irritation, fatigue, diarrhea, and bowel dysfunction. Proton therapy, a type of targeted radiation delivery, aims to reduce these side effects by minimizing radiation exposure to surrounding healthy tissues. This approach may help decrease the incidence of severe skin reactions, gastrointestinal issues, and long-term bowel complications compared to conventional radiation therapy.

What prior FDA approvals exist?

The FDA has approved several treatments for anal cancer, primarily focusing on chemoradiation therapy, which combines chemotherapy and radiation therapy. Standard radiation therapy techniques, such as external beam radiation therapy (EBRT), are commonly used. Proton therapy, a type of targeted radiation delivery, is being studied for its potential to reduce side effects by minimizing radiation exposure to surrounding healthy tissues. While proton therapy itself may not yet be FDA-approved specifically for anal cancer, it represents an advancement in radiation techniques that could improve patient outcomes.

What other types of research exist?

Promising novel alternatives to Proton Therapy for anal cancer patients include Intensity-Modulated Radiation Therapy (IMRT) and Stereotactic Body Radiation Therapy (SBRT). Both techniques offer precise targeting of tumors while minimizing damage to surrounding healthy tissues, potentially reducing side effects. Additionally, advancements in immunotherapy, such as immune checkpoint inhibitors, are being explored for their efficacy in treating anal cancer.

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Chemotherapy

Proton Therapy for Anal Cancer

Phase 2

Waitlist Available

Led By Jordan Kharofa, MD

Research Sponsored by Jordan Kharofa

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 6 months up to 60 months

Awards & highlights

Summary

This trial is testing if Proton Therapy can reduce radiation exposure to healthy areas around anal cancer, aiming to lessen side effects compared to standard treatments. Proton therapy is an emerging treatment for cancer that may have distinct advantages over conventional radiotherapy, particularly in minimizing radiation dose to surrounding normal tissue.

Who is the study for?

This trial is for individuals with a specific type of anal cancer (squamous or basaloid carcinoma) that's at a certain stage (T2-4, any N category). Participants must be relatively active and able to care for themselves (Karnofsky Performance Status >70%). Those expected to live less than 3 months cannot join.

What is being tested?

The study is testing if Proton Therapy can reduce the radiation received by healthy tissues around anal cancer compared to standard therapy. The goal is to see if this method lowers side effects while treating the cancer effectively.

What are the potential side effects?

Potential side effects may include skin reactions, fatigue, digestive issues like nausea or diarrhea from chemotherapy, and other typical reactions associated with radiation therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 6 months up to 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 6 months up to 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 6 months up to 60 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Rates of Acute Toxicity

Secondary study objectives

Complete Response Rate

Distant Metastases Free Survival

Local Progression Free Survival

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Proton Therapy and ChemotherapyExperimental Treatment2 Interventions

Standard chemoradiation using 5-FU, Mitomycin, with pencil beam proton radiotherapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mitomycin

FDA approved

Proton therapy

2011

N/A

~30

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Radiation therapy, including proton therapy, is a common treatment for anal cancer. It works by using high-energy particles or waves, such as X-rays or protons, to damage the DNA of cancer cells, which inhibits their ability to grow and divide. Proton therapy is a type of targeted radiation delivery that allows for more precise targeting of the tumor while minimizing damage to surrounding healthy tissues. This precision is particularly important for anal cancer patients because it reduces the risk of side effects and complications, thereby improving the patient's quality of life during and after treatment.

Find a Location

Who is running the clinical trial?

Jordan KharofaLead Sponsor

1 Previous Clinical Trials

Jordan Kharofa, MDPrincipal InvestigatorUniversity of Cincinnati

1 Previous Clinical Trials

Media Library

Chemotherapy (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03018418 — Phase 2

Anal Cancer Research Study Groups: Proton Therapy and Chemotherapy

Anal Cancer Clinical Trial 2023: Chemotherapy Highlights & Side Effects. Trial Name: NCT03018418 — Phase 2

Chemotherapy (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03018418 — Phase 2

~2 spots leftby Sep 2025

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