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: October 8, 2014
Last verified: October 2014
  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:


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

Primary Outcome Measures:
  • Participant local recurrence following post operative baseline assessment [ Time Frame: Baseline to disease progression, assessed annually ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 15
Study Start Date: September 2006
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00496119     History of Changes
Other Study ID Numbers: 2005-0038, NCI-2012-01509
Study First Received: July 2, 2007
Last Updated: October 8, 2014
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
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal

ClinicalTrials.gov processed this record on October 23, 2014