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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year after radiation treatments
Awards & highlights

Study Summary

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

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.Check my eligibility
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.See study design
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
Select...
My cancer is a confirmed chordoma located at the base of my skull.
Select...
I can care for myself but may need occasional help.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to Local Recurrence

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

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,762 Total Patients Enrolled
2 Trials studying Chordoma
79 Patients Enrolled for Chordoma
David Grosshans, MD, PHDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Proton Beam Therapy (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00496119 — Phase 2
Chordoma Research Study Groups: 70 Gray (Gy) Proton Beam Therapy, Photon Beam Therapy
Chordoma Clinical Trial 2023: Proton Beam Therapy Highlights & Side Effects. Trial Name: NCT00496119 — Phase 2
Proton Beam Therapy (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00496119 — Phase 2
Chordoma Patient Testimony for trial: Trial Name: NCT00496119 — Phase 2

Frequently Asked Questions

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

Is Proton Beam Therapy a reliable method of treatment for individuals?

"The safety of Proton Beam Therapy was assessed at a score of 2 since this is a Phase 2 clinical trial, which implies there are some data points that support its security but none that verify its effectiveness."

Answered by AI

Does this trial currently accept participants?

"As per clinicaltrials.gov, this medical trial is not enrolling any more patients at the present moment. This study was originally advertised on September 1st 2006 and last updated May 26th 2022; however, 27 other trials are actively accepting participants right now."

Answered by AI

Who else is applying?

What site did they apply to?
University of Texas MD Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I hope thus clinical trial help me.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

Do I have to pay for the treatment? How long will my treatment process take?
PatientReceived 2+ prior treatments
~1 spots leftby Dec 2024