Proton Beam Therapy for Chondrosarcoma

Phase 2

Waitlist Available

Led By David Grosshans, MD,PHD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

The patient has been assessed by MDACC skull base surgeons to have undergone maximal surgical debulking of disease

Karnofsky Performance status greater than or equal to 60

Must not have

Previous irradiation of the skull base

Documented evidence of disseminated metastatic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to local recurrence (evaluation every six months during estimated 5 year study)

Awards & highlights

No Placebo-Only Group

Summary

This trial will study whether proton beam therapy, with or without photon beam radiation, is effective in treating skull base chondrosarcoma. The safety of this treatment will also be studied.

Who is the study for?

This trial is for individuals with a type of bone cancer called chondrosarcoma located at the base of the skull. Participants should have had most of their tumor surgically removed, be able to perform daily activities with minimal assistance (Karnofsky Performance status ≥60), and must provide signed consent. They cannot join if they have cancer spread throughout the body or previous radiation treatment to the skull base.

What is being tested?

The study is examining how effective proton beam therapy is on its own or combined with photon beam radiation in treating skull base chondrosarcoma. Researchers want to see how well these therapies work and monitor their safety for patients.

What are the potential side effects?

Potential side effects from proton beam therapy may include skin redness, soreness, fatigue, hair loss at the treatment site, headaches, and nausea. The exact side effects can vary based on individual patient factors.

Eligibility Criteria

Inclusion Criteria

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

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I've had surgery to remove as much of my skull base tumor as possible.

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I can care for myself but may not be able to do active work.

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My cancer is a Grade 1-3 chondrosarcoma located at the base of my skull.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had radiation treatment on the base of my skull.

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My cancer has spread to other parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to local recurrence (evaluation every six months during estimated 5 year study)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to local recurrence (evaluation every six months during estimated 5 year study)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to local recurrence (evaluation every six months during estimated 5 year study) for reporting.