Proton Beam Therapy for Chordoma Patients - Full Text View

Purpose

Primary Objective:

To compare the efficacy of 70 Gy versus 78 Gy in the proton beam treatment of skull base chordoma.

Secondary Objectives:

To determine the patterns of failure of the treatment using dosimetric parameters.
To measure and characterize the late effects of proton therapy treatment by conducting longitudinal neuroimaging, neuropsychological, neuro-endocrine, neuro-ophthalmological testing, and audiometry.

Condition	Intervention	Phase
Chordoma	Radiation: Proton Beam Therapy	Phase II

MedlinePlus related topics:

Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Official Title:	Phase II Randomized Trial of 70 Gy Versus 78 Gy Proton Beam Therapy for Skull Base Chordoma

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

Primary Outcome Measures:

The goal of this clinical research study is to compare the effectiveness of 2 different doses of proton beam therapy in the treatment of skull base chordoma. [ Time Frame: 6 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Researchers will also study the safety of this therapy. [ Time Frame: 6 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	75
Study Start Date:	September 2006
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Proton Beam Therapy at 70 Gy	Radiation: Proton Beam Therapy 70 Gy once daily at 2 CGE per fraction.
2: Experimental Proton Beam Therapy at 78 Gy	Radiation: Proton Beam Therapy 78 Gy once daily at 2 CGE per fraction.

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.

Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have a magnetic resonance imaging (MRI) and computerized tomography (CT) scan of the skull base within 30 days before starting treatment. You will have neuropsychological testing and hearing and vision tests, including formal visual field testing. The neurological exam involves testing upper and lower motor strength, sensation to light touch, reflexes, a mental exam, and an evaluation of the way you walk. Blood (about 1 teaspoon) will also be collected for routine tests. Women who are able to have children must have a negative blood or urine pregnancy test.

If you are eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to participate in one of two groups. All participants will receive proton beam therapy 1 time a day. One group will receive a higher dose level than the other group. You have an equal chance of being assigned to the groups.

You will begin proton beam therapy no sooner than 2 weeks after your last surgery to remove tumor. You should receive between 35-39 treatments, depending on what group you are assigned to. The study will be monitored so that if one dose of the therapy appears to be better for participants than the other, participants on the less effective dose will be moved over to the other group.

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 75 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:

Pathologically confirmed chordoma of the skull base
Contrast enhanced postoperative MRI 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496119

Contacts


Contact: Eric L. Chang, MD	713-563-2300

Locations


United States, Texas
	U.T.M.D. Anderson Cancer Center	Recruiting
	Houston, Texas, United States, 77030
	Principal Investigator: Eric L. Chang, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators


Principal Investigator:	Eric L. Chang, MD	U.T.M.D. Anderson Cancer Center

More Information

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

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Eric L. Chang, MD/Associate Professor )
Study ID Numbers:	2005-0038
First Received:	July 2, 2007
Last Updated:	September 17, 2008
ClinicalTrials.gov Identifier:	NCT00496119
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

Study placed in the following topic categories:

Neoplasms, Germ Cell and Embryonal

Chordoma

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 06, 2008

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00496119