Proton Therapy for Anal Cancer

Recruiting in Palo Alto (17 mi)

Overseen ByJordan Kharofa, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Jordan Kharofa

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

Histologically documented squamous or basaloid carcinoma of the anal canal

Karnofsky Performance Status >70%

Your cancer has spread beyond its original location (Stage T2-4) and may have spread to nearby lymph nodes (any N category).

Exclusion Criteria

Doctors do not expect you to live more than 3 months.

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: Proton Therapy and ChemotherapyExperimental Treatment2 Interventions

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

Chemotherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺 Approved in European Union as Chemotherapy for: