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Proton Beam Therapy
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to local recurrence (evaluation every six months during estimated 5 year study)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I've had surgery to remove as much of my skull base tumor as possible.
Select...
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.
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)
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
1Treatment groups
Experimental Treatment
Group I: Proton Beam TherapyExperimental Treatment1 Intervention
Proton Beam Therapy - A total dose of up to 70 CGE given at 2.0 CGE per daily fraction for 35 fractions.
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
2,976 Previous Clinical Trials
1,789,493 Total Patients Enrolled
3 Trials studying Chondrosarcoma
148 Patients Enrolled for Chondrosarcoma
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 at M. D. Anderson within the last 3 months.I've had surgery to remove as much of my skull base tumor as possible.My cancer is a Grade 1-3 chondrosarcoma located at the base of my skull.I have had radiation treatment on the base of my skull.My cancer has spread to other parts of my body.I can care for myself but may not be able to do active work.
Research Study Groups:
This trial has the following groups:- Group 1: Proton 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this treatment have the endorsement of the Food and Drug Administration?
"The safety rating for this testing intervention is a 2, as the current clinical data only supports its security but not yet efficacy. This evaluation falls under Phase 2 trials."
Answered by AI
Are there still vacancies for participants in this research study?
"Per the information hosted on clinicaltrials.gov, this particular medical trial is not presently recruiting participants. It initially appeared online on April 28th 2006 and was last adjusted on August 25th 2022. However, 24 other trials are currently enlisting volunteers."
Answered by AI
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