ClinicalTrials.gg
Active, not recruitingNCT00496522Updated Sep 29, 2026

Proton Beam Therapy for Chondrosarcoma

A Phase 2 interventional study of Proton Beam Therapy in Chondrosarcoma, sponsored by M.D. Anderson Cancer Center. Active, not recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Apr 2006, registered Jul 2007).
Updated Sep 29, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Sex
All
01

Study 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 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.

02

Conditions studied

  • Chondrosarcoma

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Keywords

  • Skull Base Chondrosarcoma
  • Proton Beam Therapy
  • Chondrosarcoma
  • CNS
03

In context

Chondrosarcoma

99 studies on the registry are indexed under Chondrosarcoma; 20 are open to participants now.

This study's enrollment of 15 is below the median of 52 across 72 interventional studies indexed under Chondrosarcoma.

Browse Chondrosarcoma studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 3,047 studies on the registry; 578 are open to participants now.

Of its 612 completed or terminated interventional studies of FDA-regulated products, 409 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. confirmed Grade 1-3 chondrosarcoma of the skull base
  2. Contrast enhanced postop MRI or CT if there is clinical for MRI of the skull base obtained with 90 days of study registration at M. D. Anderson
  3. The patient has been assessed by MDACC skull base surgeons to have undergone maximal surgical debulking of disease
  4. Performance status greater than or equal to 60
  5. Signed

Exclusion criteria

Exclusion Criteria:

  1. Previous irradiation of the skull base
  2. Documented evidence of disseminated disease
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Other
    Proton Beam Therapy

    Proton Beam Therapy - A total dose of up to 70 CGE given at 2.0 CGE per daily fraction for 35 fractions.

    Procedure: Proton Beam Therapy

Interventions

  • ProcedureProton Beam Therapy

    A total dose of up to 70 CGE given at 2.0 CGE per daily fraction for 35 fractions.

06

What researchers measure

Primary outcomes

  1. Time to Local Recurrence

    Local recurrence defined as progression on magnetic resonance imaging (MRI) or CT if MRI is contraindicated.

    Time frame: Baseline to local recurrence (evaluation every six months during estimated 5 year study)

07

Study locations

1 site
08

References and documents

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started Apr 2006 (actual). Primary completion is estimated for Aug 2028, 267 months after the start.

Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 29, 2026: primary completion Aug 2026 → Aug 2028 and completion Aug 2026 → Aug 2028.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jul 2, 2007
First posted
Jul 4, 2007
StartActual
Apr 28, 2006
Primary completionEst.
Aug 19, 2028was Aug 2026
CompletionEst.
Aug 19, 2028was Aug 2026
Last update
Sep 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Aug 19, 2026→Aug 19, 2028
Sep 29, 2026
Study completion
Aug 19, 2026→Aug 19, 2028
Sep 29, 2026
Show all 1 update
  1. Sep 29, 2026
    Primary completion Aug 19, 2026→Aug 19, 2028
    Study completion Aug 19, 2026→Aug 19, 2028
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT00496522
Responsible party
Sponsor
First posted
Jul 4, 2007
Start date
Apr 28, 2006
Primary completion
Aug 19, 2028 (estimated)
Completion
Aug 19, 2028 (estimated)
Last update
Sep 29, 2026

Study contacts

David Grosshans, MD,PHD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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