MDACC Study Summary 2004-0915

Study Summary
No. 2004-0915:.......CNS......David Grosshans......Radiation Oncology

Study Summary Title



Study Summary Number:	2004-0915

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

Physician

New Patient Referral



Name:	David Grosshans	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 II	Return Visit:	every 6 months

Treatment Agents:	Radiation	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 learn if proton beam therapy is effective in the treatment of skull base chondrosarcoma. The safety of this treatment will also be studied.

Study Objectives / Outcomes

Primary
1. To establish the efficacy of proton beam therapy with and without photon beam radiation therapy for skull base chondrosarcoma.

Secondary
1. To determine the patterns of failure of skull base chondrosarcoma treated with surgery and proton beam therapy with and without photon beam radiation therapy.

2. To measure and characterize the late effects of proton therapy using longitudinal neuropsychological, neuro-endocrine, neuro-opthalmological and neuro-otologic testing.

Study Status Information



Study Activation / Registration Date:	04/28/2006

IRB Review and Approval Date:	08/17/2005

Study Type:	Therapeutic

Recruitment Status:	Open

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 Grade 1-3 chondrosaroma of the skull base

2) Contrast enhanced postop MRI or CT if there is clinical contraindication for MRI of the skull base obtained with 90 days of study registration at M. D. Anderson

3) The patient has been assessed by MDACC skull base surgeons to have undergone maximal surgical debulking of disease

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

Links

Registration Number: NCT00496522
Study Information on Clinical Trials Registry (clinicaltrials.gov)