This trial is active, not recruiting.

Condition chordoma
Treatments proton beam therapy, photon beam therapy
Phase phase 2
Sponsor M.D. Anderson Cancer Center
Start date September 2006
End date September 2017
Trial size 15 participants
Trial identifier NCT00496119, 2005-0038, NCI-2012-01509


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Participants treated to 70 cobalt Gray equivalent (CGE) only (the standard treatment).
proton beam therapy
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.
Proton beam therapy combined with photon radiation therapy where combination improves final dose distribution.
proton beam therapy
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
Photon beam therapy once daily, no sooner than 2 weeks after last surgery to remove tumor, for 35-39 treatments.

Primary Outcomes

Participant local recurrence following post operative baseline assessment
time frame: Baseline to disease progression, assessed annually

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Phase II Evaluation of Proton Beam Therapy for Skull Base Chordoma
Principal investigator David Grosshans, MD, PHD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.