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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

Study Summary

This trial is testing whether proton therapy can reduce side effects from anal cancer radiation while keeping the same effectiveness.

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.Check my eligibility

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.See study design

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

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

Primary outcome measures

Rates of Acute Toxicity

Secondary outcome measures

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

Proton therapy

2011

N/A

~30

Mitomycin

FDA approved

Do I qualify?Apply below to find out

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

Frequently Asked Questions

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

Are there any reports of precedential studies that have incorporated Proton therapy?

"Currently, 40 clinical trials are exploring the efficacy of Proton therapy with 10 in Phase 3. Although Bethesda, Maryland is home to many studies on this subject matter, there are also 2029 other sites conducting similar research."

Answered by AI

Are there still open positions for participation in this experiment?

"As evidenced on clinicaltrials.gov, this research was first posted in April 2017 and ended recruitment at the end of June 2021. Unfortunately, participants cannot be accepted for this specific trial; however there are 99 other studies that require patient volunteers."

Answered by AI

Under what conditions is Proton therapy usually prescribed?

"Typically, proton therapy is used to deal with cervical cancers. Yet it can also be applied in the management of lg-utuc, glaucoma, and mesotheliomas."

Answered by AI

Has Proton therapy been given the thumbs up by the FDA?

"Our assessment at Power placed proton therapy's safety rating as a 2, given that it is only in its second phase of clinical testing and efficacy data are yet to be gathered."

Answered by AI

How many participants are engaged in this clinical research?

"This research is not currently accepting participants. Initially posted on April 1st, 2017, the study was last edited on June 30th 2021. For those seeking trials for anal cancer, 59 are actively recruiting and 40 studies are searching for patients with Proton therapy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Proton Therapy in Reducing Toxicity in Anal Cancer

Jordan Kharofa 2017. "Proton Therapy in Reducing Toxicity in Anal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03018418.

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