Proton Beam Therapy for Chondrosarcoma
Primary Purpose
Chondrosarcoma
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Proton Beam Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chondrosarcoma focused on measuring Skull Base Chondrosarcoma, Proton Beam Therapy, Chondrosarcoma, CNS
Eligibility Criteria
Inclusion Criteria:
- Pathologically confirmed Grade 1-3 chondrosarcoma of the skull base
- 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
- 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
Sites / Locations
- MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Proton Beam Therapy
Arm Description
Proton Beam Therapy - A total dose of up to 70 CGE given at 2.0 CGE per daily fraction for 35 fractions.
Outcomes
Primary Outcome Measures
Time to Local Recurrence
Local recurrence defined as progression on magnetic resonance imaging (MRI) or CT if MRI is contraindicated.
Secondary Outcome Measures
Full Information
NCT ID
NCT00496522
First Posted
July 2, 2007
Last Updated
September 5, 2023
Sponsor
M.D. Anderson Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00496522
Brief Title
Proton Beam Therapy for Chondrosarcoma
Official Title
Phase II Evaluation of Proton Beam Therapy for Skull Base Chondrosarcoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 28, 2006 (Actual)
Primary Completion Date
August 19, 2024 (Anticipated)
Study Completion Date
August 19, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chondrosarcoma
Keywords
Skull Base Chondrosarcoma, Proton Beam Therapy, Chondrosarcoma, CNS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Proton Beam Therapy
Arm Type
Other
Arm Description
Proton Beam Therapy - A total dose of up to 70 CGE given at 2.0 CGE per daily fraction for 35 fractions.
Intervention Type
Procedure
Intervention Name(s)
Proton Beam Therapy
Intervention Description
A total dose of up to 70 CGE given at 2.0 CGE per daily fraction for 35 fractions.
Primary Outcome Measure Information:
Title
Time to Local Recurrence
Description
Local recurrence defined as progression on magnetic resonance imaging (MRI) or CT if MRI is contraindicated.
Time Frame
Baseline to local recurrence (evaluation every six months during estimated 5 year study)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pathologically confirmed Grade 1-3 chondrosarcoma of the skull base
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Grosshans, MD,PHD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center
Learn more about this trial
Proton Beam Therapy for Chondrosarcoma
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