14 Participants Needed

Proton Therapy for Anal Cancer

Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Jordan Kharofa
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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.

Research Team

JK

Jordan Kharofa, MD

Principal Investigator

University of Cincinnati

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard chemoradiation using 5-FU, Mitomycin, with pencil beam proton radiotherapy

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 months

Quality of Life Assessment

Utilization of the Patient Reported Outcomes- Common Toxicity Criteria for Adverse Events at pretreatment and up to 12 months

12 months

Treatment Details

Interventions

  • Chemotherapy
  • Proton therapy
Trial OverviewThe 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.
Participant Groups
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:

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Approved in European Union as Chemotherapy for:
  • Breast cancer
  • Metastatic breast cancer
  • Various other cancers
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Approved in United States as Chemotherapy for:
  • Breast cancer
  • Metastatic breast cancer
  • Various other cancers
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Approved in Canada as Chemotherapy for:
  • Breast cancer
  • Metastatic breast cancer
  • Various other cancers
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Approved in Japan as Chemotherapy for:
  • Breast cancer
  • Metastatic breast cancer
  • Various other cancers
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Approved in China as Chemotherapy for:
  • Breast cancer
  • Metastatic breast cancer
  • Various other cancers
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Approved in Switzerland as Chemotherapy for:
  • Breast cancer
  • Metastatic breast cancer
  • Various other cancers

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jordan Kharofa

Lead Sponsor

Trials
2
Recruited
10+