What is the mechanism of action of this treatment?

Chordoma treatments often include surgery, radiation therapy, and targeted therapies. Proton beam therapy, a form of targeted radiation, is particularly significant for chordoma patients due to its precision in delivering high doses of radiation to the tumor while minimizing damage to surrounding healthy tissues. This precision is crucial because chordomas are typically located near critical structures in the spine and skull base. By reducing collateral damage, proton beam therapy can potentially improve outcomes and reduce side effects, making it a promising option for managing this challenging cancer.

What side effects are associated with this type of intervention?

Proton beam therapy, often used for treating chordoma, is associated with several side effects. These can include skin reactions, fatigue, and localized pain at the treatment site. Additionally, there may be long-term risks such as damage to surrounding tissues and organs, which can lead to complications like radiation-induced secondary cancers. However, proton therapy is generally preferred for its precision in targeting tumors while minimizing exposure to healthy tissues.

What prior FDA approvals exist?

The provided context does not mention specific FDA approvals for the treatment of Chordoma. However, it does highlight the use of Proton Beam Therapy, which is being studied for its effectiveness and safety in treating skull base Chordoma. Proton Beam Therapy is a form of targeted radiation that aims to minimize damage to surrounding tissues, making it a promising option for Chordoma patients. For a comprehensive understanding of FDA-approved treatments, consulting additional sources or clinical guidelines would be necessary.

What other types of research exist?

Promising alternatives to Proton Beam Therapy for Chordoma patients include Carbon Ion Radiation Therapy, which has shown efficacy in treating high-risk meningiomas and may offer similar benefits for chordomas. Intensity-Modulated Radiotherapy (IMRT) and Stereotactic Radiosurgery (SRS) are also advanced techniques that can precisely target tumors while minimizing damage to surrounding tissues. These alternatives are supported by long-term experience and evolving research in radiation oncology.

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Proton Beam Therapy

Proton Beam Therapy for Chordoma

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

Pathologically confirmed chordoma of the skull base

Karnofsky Performance status greater than or equal to 60

Must not have

Any concurrent malignancy (other than non-melanoma skin cancers) in the last 3 years

Previous irradiation of the skull base

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year after radiation treatments

Awards & highlights

No Placebo-Only Group

Summary

This study is evaluating whether proton beam therapy is effective in the treatment of skull base chordoma.

Who is the study for?

This trial is for individuals with a confirmed diagnosis of chordoma at the base of the skull, who have had surgery to remove as much of the tumor as possible. They should be able to perform daily activities without significant assistance (Karnofsky Performance status ≥60) and must not have had previous radiation therapy in that area or any other cancer (except skin cancer) in the past three years.

What is being tested?

The study is examining whether proton beam therapy alone or combined with photon beam radiation therapy can effectively treat skull base chordoma. The research will also assess how safe these treatments are for patients.

What are the potential side effects?

Potential side effects may include skin reactions, fatigue, headaches, hair loss at treatment site, hearing problems, and more rarely damage to nearby brain tissue which could affect hormone levels or brain function.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is a confirmed chordoma located at the base of my skull.

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I can care for myself but may need occasional help.

Exclusion Criteria

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

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I have not had any cancer other than non-melanoma skin cancer in the last 3 years.

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I have had radiation therapy 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 ~ 1 year after radiation treatments

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year after radiation treatments

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year after radiation treatments for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Time to Local Recurrence

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Photon Beam TherapyExperimental Treatment2 Interventions

Proton beam therapy combined with photon radiation therapy where combination improves final dose distribution.

Group II: 70 Gray (Gy) Proton Beam TherapyExperimental Treatment1 Intervention

Participants treated to 70 cobalt Gray equivalent (CGE) only (the standard treatment).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Proton Beam Therapy

2012

N/A

~160

0 / 5Eligibility criteria met

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

Chordoma treatments often include surgery, radiation therapy, and targeted therapies. Proton beam therapy, a form of targeted radiation, is particularly significant for chordoma patients due to its precision in delivering high doses of radiation to the tumor while minimizing damage to surrounding healthy tissues. This precision is crucial because chordomas are typically located near critical structures in the spine and skull base. By reducing collateral damage, proton beam therapy can potentially improve outcomes and reduce side effects, making it a promising option for managing this challenging cancer.

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