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Proton Beam Therapy for Chordoma Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00496119
First received: July 2, 2007
Last updated: June 5, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention Phase
Chordoma
 Radiation: Proton Beam Therapy
Radiation: Photon Beam Therapy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Evaluation of Proton Beam Therapy for Skull Base Chordoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Time to Local Recurrence [ Time Frame: Yearly (Baseline to disease progression) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: September 2006
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 70 Gy Proton Beam Therapy
Participants will be treated to 70 CGE only, which is 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
The proton beam therapy may be combined with photon radiation therapy if, in the judgement of the treating radiation oncologist, the combination is felt to improve the final dose distribution.
 Radiation: Photon Beam Therapy
Photon beam therapy once daily, no sooner than 2 weeks after last surgery to remove tumor, for 35-39 treatments.

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 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 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 M. D. Anderson.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00496119

Locations
United States, Texas
U.T.M.D. 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
  More Information

Additional Information:
UT MD Anderson Cancer Center website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00496119     History of Changes
Other Study ID Numbers: 2005-0038
Study First Received: July 2, 2007
Last Updated: June 5, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013