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Phase II Evaluation of Proton Beam Therapy for Skull Base Chordoma

Phase 2
Open (Enrolling)

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Trial Information

Phase II Evaluation of Proton Beam Therapy for Skull Base Chordoma

Proton therapy is a kind of external beam radiation therapy where protons are directed to a
tumor site. Researchers are trying to determine what level of proton therapy gives the most
benefit without causing toxic side effects. Researchers will also be testing the treatment's

If your doctor feels it is necessary, the proton beam therapy may be combined with standard
photon therapy.

If you are eligible to take part in this study, you will receive proton beam therapy, and
possibly photon beam, no sooner than 2 weeks after the last surgery to remove the 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

This is an investigational study. The proton beam machine used to deliver treatment is
approved by the FDA for patient use. The doses being studied are experimental. About 15
participants will take part in this study. All will be enrolled at M. D. Anderson.

Inclusion Criteria:

1. Pathologically confirmed chordoma of the skull base

2. Contrast enhanced postoperative MRI (CT in case MRI is contraindicated) of the skull
base obtained within 90 days of study registration

3. MDACC surgeons have determined that optimal debulking of disease has been performed.

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

3. Any concurrent malignancy (other than non-melanoma skin cancers) in the last 3 years

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to Local Recurrence

Outcome Time Frame:

Yearly (Baseline to disease progression)

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:

September 2006

Completion Date:

Related Keywords:

  • Chordoma
  • Proton Beam Therapy
  • Skull Base Chordoma
  • Chordoma of the Skull Base
  • Chordoma
  • Chordoma



U.T.M.D. Anderson Cancer Center Houston, Texas  77030