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Proton Beam Therapy for Chordoma Patients

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ClinicalTrials.gov Identifier: NCT00496119
Recruitment Status : Active, not recruiting
First Posted : July 4, 2007
Last Update Posted : October 25, 2017
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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

Condition or disease Intervention/treatment Phase
Chordoma Radiation: Proton Beam Therapy Radiation: Photon Beam Therapy Phase 2

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Evaluation of Proton Beam Therapy for Skull Base Chordoma
Actual Study Start Date : September 2006
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 70 Gray (Gy) Proton Beam Therapy
Participants treated to 70 cobalt Gray equivalent (CGE) only (the standard treatment).
Radiation: 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.
Experimental: Photon Beam Therapy
Proton beam therapy combined with photon radiation therapy where combination improves final dose distribution.
Radiation: 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.
Radiation: Photon Beam Therapy
Photon beam therapy once daily, no sooner than 2 weeks after last surgery to remove tumor, for 35-39 treatments.



Primary Outcome Measures :
  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.




Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00496119


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: David Grosshans, MD, PHD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00496119     History of Changes
Other Study ID Numbers: 2005-0038
NCI-2012-01509 ( Registry Identifier: NCI CTRP )
First Posted: July 4, 2007    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017

Keywords provided by M.D. Anderson Cancer Center:
Proton Beam Therapy
Skull Base Chordoma
Chordoma of the Skull Base
Chordoma

Additional relevant MeSH terms:
Chordoma
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms