Proton Beam Therapy for Chondrosarcoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00496522
First received: July 2, 2007
Last updated: July 15, 2014
Last verified: July 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 chondrosarcoma. The safety of this treatment will also be studied.


Condition Intervention Phase
Chondrosarcoma
Procedure: Proton Beam Therapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Evaluation of Proton Beam Therapy for Skull Base Chondrosarcoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Time to Local Recurrence [ Time Frame: Baseline to local recurrence (evaulation every six months during estimated 5 year study) ] [ Designated as safety issue: No ]
    Local recurrence defined as progression on magnetic resonance imaging (MRI) or CT if MRI is contraindicated.


Estimated Enrollment: 15
Study Start Date: April 2006
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Proton Beam Therapy
Proton Beam Therapy - A total dose of up to 70 CGE given at 2.0 CGE per daily fraction for 35 fractions.
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.

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.

If your doctor feels it is necessary, the proton beam therapy may be combined with standard photon therapy.

After the proton beam, and possibly photon beam, therapy, you will be asked to come in for study follow-up visits every year, 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 MD 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 15 patients will take part in this study. All will be enrolled at MD Anderson.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pathologically confirmed Grade 1-3 chondrosarcoma 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
  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: NCT00496522

Locations
United States, Texas
UT 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: NCT00496522     History of Changes
Other Study ID Numbers: 2004-0915, NCI-2012-01510
Study First Received: July 2, 2007
Last Updated: July 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Skull Base Chondrosarcoma
Proton Beam Therapy
Chondrosarcoma
CNS

Additional relevant MeSH terms:
Chondrosarcoma
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma

ClinicalTrials.gov processed this record on October 02, 2014