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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year after radiation treatments
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year after radiation treatments
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
2,987 Previous Clinical Trials
1,797,995 Total Patients Enrolled
2 Trials studying Chordoma
79 Patients Enrolled for Chordoma
David Grosshans, MD, PHDPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had a detailed brain scan within the last 3 months.I have not had any cancer other than non-melanoma skin cancer in the last 3 years.I have had radiation therapy on the base of my skull.My cancer is a confirmed chordoma located at the base of my skull.I can care for myself but may need occasional help.My surgeon has removed as much of the cancer as possible.My cancer has spread to other parts of my body.
Research Study Groups:
This trial has the following groups:- Group 1: 70 Gray (Gy) Proton Beam Therapy
- Group 2: Photon Beam Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Chordoma Patient Testimony for trial: Trial Name: NCT00496119 — Phase 2
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