MDACC Study Summary 2005-0038

Study Summary
No. 2005-0038:.......CNS......Eric L. Chang......Radiation Oncology

Study Summary Title



Study Summary Number:	2005-0038

Study Title:	Phase II Evaluation of Proton Beam Therapy for Skull Base Chordoma

Physician

New Patient Referral



Name:	Eric L. Chang	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Radiation Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-563-2300 Contact us about clinical trials

General Information



Disease Group:	CNS	Supported By:	N/A

Phase of Study:	Phase III	Return Visit:	The patient will return for follow-up visits every year after completion of proton beam therapy.

Treatment Agents:	Proton Therapy	Home Care:	N/A

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	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. Researchers will also study the safety of this therapy.

Study Objectives / Outcomes

Primary Objectives:

To establish the efficacy of proton beam therapy with or without photon beam radiation therapy for skull base chordoma.

Secondary Objectives:
1. To determine the patterns of failure of the treatment using dosimetric parameters

2. To measure and characterize the late effects of proton therapy treatment by conducting longitudinal neuroimaging, neuropsychological, neuro-endocrine, neuro-opthalmological testing and audiometry.

Study Status Information



Study Activation / Registration Date:	09/18/2006

IRB Review and Approval Date:	08/17/2005

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Closed

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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

Links

Registration Number: NCT00496119
Study Information on Clinical Trials Registry (clinicaltrials.gov)