ChondrosarcomaPhase 2NCT00496522
Proton Beam Therapy for Chondrosarcoma
A Phase 2 study testing Proton Beam Therapy in people with Chondrosarcoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if proton beam therapy, with or without photon beam radiation therapy, is effective in the treatment of skull base chondrosarcoma. The safety of this treatment will also be studied. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chondrosarcoma
- What is being tested?
- Proton Beam Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2006to 19 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pathologically confirmed Grade 1-3 chondrosarcoma of the skull base
- Contrast enhanced postop MRI or CT if there is clinical contraindication for MRI of the skull base obtained with 90 days of study registration at M. D. Anderson
- 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
- Signed informed consent
Who cannot join
- Previous irradiation of the skull base
- Documented evidence of disseminated metastatic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Evaluation of Proton Beam Therapy for Skull Base Chondrosarcoma
The goal of this clinical research study is to learn if proton beam therapy, with or without photon beam radiation therapy, is effective in the treatment of skull base chondrosarcoma. The safety of this treatment will also be studied.
Read the detailed description
Patients who have skull base chondrosarcoma require complicated treatment because of its challenging location and nearness to critical structures within the brain.
Pathology will be confirmed prior to discussion of the study.
If you are found to be eligible to take part in this study, you will receive proton beam therapy, no sooner than 2 weeks after the last surgery to remove tumor. You will receive proton beam therapy once a day for about 35 treatments (7 weeks). Treatment will be given for 5 days in a row each week (except for Saturdays, Sundays, and holidays) at the Proton Center in Houston. The whole process should take up to 1 hour each day.
If your doctor feels it is necessary, the proton beam therapy may be combined with standard photon therapy.
After the proton beam, and possibly photon beam, therapy, you will be asked to come in for study follow-up visits every year, until the study is completed. At these visits, you will have magnetic resonance imaging (MRI) scans, blood draws (less than 1 teaspoon) to monitor your pituitary function, and neuropsychological testing. For the neuropsychological testing, you will be interviewed and tested by a neuropsychologist to evaluate your memory, fluency (the ability to talk and form words) complex thinking ability, planning ability, and coordination. These tests could last from 1-2 hours. You will also have eye exams performed by an ophthalmologist from MD Anderson and hearing exams. It is anticipated that it will take about 5 years to complete this study.
This is an investigational study. The proton beam center and its treatment are approved by the FDA for patient use. A total of up to 15 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Chondrosarcoma
- Being tested
- Proton Beam Therapy
- Keywords
- Skull Base Chondrosarcoma, Proton Beam Therapy, Chondrosarcoma, CNS
- Medical subject headings
- Chondrosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton Beam TherapyProcedure or surgery
A total dose of up to 70 CGE given at 2.0 CGE per daily fraction for 35 fractions.
| Study group | Role | What they receive |
|---|---|---|
| Proton Beam Therapy | Other | Proton Beam Therapy - A total dose of up to 70 CGE given at 2.0 CGE per daily fraction for 35 fractions. Receives: Procedure: Proton Beam Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Local Recurrence
Local recurrence defined as progression on magnetic resonance imaging (MRI) or CT if MRI is contraindicated.
Measured: Baseline to local recurrence (evaluation every six months during estimated 5 year study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2007 (estimated)
- Study start28 Apr 2006
- Primary completion19 Aug 2028 (estimated)
- Study completion19 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChondrosarcomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Grosshans, MD,PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00496522
- Sponsor's protocol ID
- 2004-0915
- Other IDs
- NCI-2012-01510
- Status last verified
- Sep 2026
- First submitted
- 2 Jul 2007
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Evaluation of Proton Beam Therapy for Skull Base Chondrosarcoma
- ClinicalTrials.gov ID
- NCT00496522
- Acronym / sponsor ID
- 2004-0915
- Conditions
- Chondrosarcoma
- Keywords
- Skull Base Chondrosarcoma, Proton Beam Therapy, Chondrosarcoma, CNS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 28 Apr 2006 (actual)
- Primary completion
- 19 Aug 2028 (estimated)
- Study completion
- 19 Aug 2028 (estimated)
- First posted
- 4 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if proton beam therapy, with or without photon beam radiation therapy, is effective in the treatment of skull base chondrosarcoma. The safety of this treatment will also be studied.
Detailed description
Patients who have skull base chondrosarcoma require complicated treatment because of its challenging location and nearness to critical structures within the brain.
Pathology will be confirmed prior to discussion of the study.
If you are found to be eligible to take part in this study, you will receive proton beam therapy, no sooner than 2 weeks after the last surgery to remove tumor. You will receive proton beam therapy once a day for about 35 treatments (7 weeks). Treatment will be given for 5 days in a row each week (except for Saturdays, Sundays, and holidays) at the Proton Center in Houston. The whole process should take up to 1 hour each day.
If your doctor feels it is necessary, the proton beam therapy may be combined with standard photon therapy.
After the proton beam, and possibly photon beam, therapy, you will be asked to come in for study follow-up visits every year, until the study is completed. At these visits, you will have magnetic resonance imaging (MRI) scans, blood draws (less than 1 teaspoon) to monitor your pituitary function, and neuropsychological testing. For the neuropsychological testing, you will be interviewed and tested by a neuropsychologist to evaluate your memory, fluency (the ability to talk and form words) complex thinking ability, planning ability, and coordination. These tests could last from 1-2 hours. You will also have eye exams performed by an ophthalmologist from MD Anderson and hearing exams. It is anticipated that it will take about 5 years to complete this study.
This is an investigational study. The proton beam center and its treatment are approved by the FDA for patient use. A total of up to 15 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proton Beam Therapy | Other | Procedure: Proton Beam TherapyProton Beam Therapy - A total dose of up to 70 CGE given at 2.0 CGE per daily fraction for 35 fractions. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Pathologically confirmed Grade 1-3 chondrosarcoma of the skull base
- Contrast enhanced postop MRI or CT if there is clinical contraindication for MRI of the skull base obtained with 90 days of study registration at M. D. Anderson
- 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
- Signed informed consent
Key exclusion criteria (2 listed)
- Previous irradiation of the skull base
- Documented evidence of disseminated metastatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proton Beam TherapyA total dose of up to 70 CGE given at 2.0 CGE per daily fraction for 35 fractions. | Procedure or surgery | Proton Beam Therapy |
Primary outcome
Time to Local Recurrence
Time frame: Baseline to local recurrence (evaluation every six months during estimated 5 year study)
Local recurrence defined as progression on magnetic resonance imaging (MRI) or CT if MRI is contraindicated.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Grosshans, MD,PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Proton Beam Therapy in people with Chondrosarcoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Local Recurrence (time frame: Baseline to local recurrence (evaluation every six months during estimated 5 year study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026; AzTrials last refreshed its copy on 27 Oct 2026.