Proton Beam Therapy for Chondrosarcoma - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00496522

Purpose

Primary Objective:

To establish the efficacy of proton beam therapy for skull base chondrosarcoma.

Secondary Objectives:

To determine the patterns of failure of skull base chondrosarcoma treated with surgery and proton beam therapy.
To measure and characterize the late effects of proton therapy using longitudinal neuropsychological, neuro-endocrine, neuro-ophthalmological, and neuro-otologic testing.

Condition	Intervention	Phase
Chondrosarcoma	Procedure: Proton Beam Therapy	Phase II

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Evaluation of Proton Beam Therapy for Skull Base Chondrosarcoma

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

Primary Outcome Measures:

To learn if proton beam therapy is effective in the treatment of skull base chondrosarcoma. [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To study the safety of this treatment. [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	70
Study Start Date:	April 2006
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Proton Beam Therapy	Procedure: Proton Beam Therapy A total dose of up to 70 CGE given at 2.0 CGE per daily fraction for 35 fractions.

Detailed Description:

Patients who have skull base chondrosarcoma require complicated treatment because of its challenging location and nearness to critical structures within the brain.

Pathology will be confirmed prior to discussion of the study.

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. Women who are able to have children must have a negative blood or urine pregnancy test. You will have an evaluation to learn if additional surgery to remove more tumor is possible. If further surgery is needed, the proton therapy (radiation) will be given (if needed) after you heal from surgery.

If you are found to be eligible to take part in this study, you will receive proton beam therapy, no sooner than 2 weeks after the last surgery to remove 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.

After the proton beam therapy, you will be asked to come in for study follow-up visits every 6 months, until the study is completed. At these visits, you will have magnetic resonance imaging (MRI) scans, blood draws (less than 1 teaspoon) to monitor your pituitary function, and neuropsychological testing. For the neuropsychological testing, you will be interviewed and tested by a neuropsychologist to evaluate your memory, fluency (the ability to talk and form words) complex thinking ability, planning ability, and coordination. These tests could last from 1-2 hours. You will also have eye exams performed by an ophthalmologist from M. D. Anderson and hearing exams. It is anticipated that it will take about 5 years to complete this study.

This is an investigational study. The proton beam center and its treatment are approved by the FDA for patient use. A total of up to 70 patients 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 Grade 1-3 chondrosarcoma of the skull base
Contrast enhanced MRI of the skull base obtained with 30 days of study registration at M. D. Anderson
The patient has been assessed by MDACC skull base surgeons to have undergone maximal surgical debulking of disease
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496522

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:	2004-0915
Study First Received:	July 2, 2007
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00496522
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Skull Base Chondrosarcoma
Proton Beam Therapy
Chondrosarcoma
CNS

Study placed in the following topic categories:

Neoplasms, Connective and Soft Tissue
Malignant mesenchymal tumor
Chondrosarcoma
Sarcoma
Soft tissue sarcomas

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective Tissue

ClinicalTrials.gov processed this record on January 16, 2009