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Phase II Evaluation of Proton Beam Therapy for Skull Base Chondrosarcoma

Phase 2
Open (Enrolling)

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Trial Information

Phase II Evaluation of Proton Beam Therapy for Skull Base Chondrosarcoma

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.

Inclusion Criteria:

1. Pathologically confirmed Grade 1-3 chondrosarcoma of the skull base

2. 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

3. The patient has been assessed by MDACC skull base surgeons to have undergone maximal
surgical debulking of disease

4. Karnofsky Performance status greater than or equal to 60

5. Signed informed consent

Exclusion Criteria:

1. Previous irradiation of the skull base

2. Documented evidence of disseminated metastatic disease

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to Local Recurrence (local recurrence defined as progression on MRI or CT if MRI is contraindicated)

Outcome Time Frame:

Baseline to local recurrence (evaulation every six months during estimated 5 year study)

Safety Issue:


Principal Investigator

David Grosshans, MD,PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

April 2006

Completion Date:

Related Keywords:

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



UT MD Anderson Cancer Center Houston, Texas  77030