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Active, Not Recruiting

NCT Number: NCT00496119

Proton Beam Therapy for Chordoma Patients

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 chordoma. The safety of this treatment will also be studied.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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 effect.

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 at The University of Texas (UT) MD Anderson Cancer Center (MDACC), 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 MDACC Proton Center in Houston. The whole process should take up to 1 hour each day.

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 MDACC.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pathologically confirmed chordoma of the skull base
  • Contrast enhanced postoperative MRI (CT in case MRI is contraindicated) of the skull base obtained within 90 days of study registration
  • MDACC surgeons have determined that optimal debulking of disease has been performed.
  • Karnofsky Performance status greater than or equal to 60
  • Signed informed consent

Exclusion criteria

  • Previous irradiation of the skull base
  • Documented evidence of disseminated metastatic disease
  • Any concurrent malignancy (other than non-melanoma skin cancers) in the last 3 years

Treatment and study plan

Proton beam therapy

Radiation

70 Gy once daily at 2 CGE per fraction, no sooner than 2 weeks after last surgery to remove tumor, for between 35-39 treatments.

Photon Beam Therapy

Radiation

Photon beam therapy once daily, no sooner than 2 weeks after last surgery to remove tumor, for 35-39 treatments.

Primary outcomes

  1. Time to Local Recurrence

    Time frame: 1 year after radiation treatments

    Recurrence classified as "central," "in-field", "marginal," "peripheral," or "distant" depending upon its relationship to the dose distribution on the original treatment plan.

    MRI (or CT in case MRI is contraindicated) of the skull base used to document the status of disease in the following categories: 1) stable disease, 2) progressive disease, 3) partial response/complete response. A post-operative MRI (or CT) obtained within 90 days of study registration serves as baseline with annual follow up till disease progression or death for any reason.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

Phase II Evaluation of Proton Beam Therapy for Skull Base Chordoma

Important dates

Study start
2006
Primary completion
2027
Study completion
2027
First posted
Jul 4, 2007
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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