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Proton Beam Therapy for Chondrosarcoma

StatusActive, Not Recruiting
PhasePhase 2
Started2006-04-28
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 24 months later Aug 19, 2026 → Aug 19, 2028
See other at-risk trials from M.D. Anderson Cancer Center

Amendment history

2026-09-30
Primary completion pushed: 2026-08-19 → 2028-08-19
Completion pushed: 2026-08-19 → 2028-08-19
2026-03-05
4 amendments v31-v34
4 re-verifications since 2024-09-13, no change to tracked fields
2024-09-09
Study Status, Oversight v30
Primary completion date2024-08-19→2026-08-19
Completion date2024-08-19→2026-08-19
2024-03-18
3 amendments v27-v29
3 re-verifications since 2023-02-24, no change to tracked fields
2022-08-25
Study Status v26
Start date2006-04→2006-04-28
Show 25 earlier versions
2022-05-25
Study Identification, Study Status, Contacts/Locations, References v25
Study sites1 entry, revised
University of Texas MD Anderson Cancer Center
2020-11-23
Study Status, Study Design v24
Re-verified, no change to tracked fields
2019-05-14
Study Status v23
Primary completion date2019-04→2024-08-19
Completion date2019-04→2024-08-19
2018-07-11
Study Status v22
Re-verified, no change to tracked fields
2017-07-10
Study Status, Oversight, Outcome Measures v21
Primary completion date2017-04→2019-04
Completion datenot stated→2019-04
2016-07-27
Study Status v20
Re-verified, no change to tracked fields
2015-07-16
Study Status, Contacts/Locations v19
Primary completion date2016-04→2017-04
Study sites1 entry, revised
UTUniversity of Texas MD Anderson Cancer Center
2014-07-15
Recruiting→Active, Not Recruiting Study Identification, Study Status, Contacts/Locations, References v18
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2015-04→2016-04
Study sitesdetails revised at 1 of 1 site
2014-03-04
Study Status, Outcome Measures v17
Primary endpoints1 entry, revised
Time to Local Recurrence (local recurrence defined as progression on MRI or CT if MRI is contraindicated)
2013-10-08
Study Status v16
Re-verified, no change to tracked fields
2013-04-29
Study Status, Study Description v15
Study description-6 characters
[...] ll also have eye exams performed by an ophthalmologist from M. D.MD Anderson and hearing exams. It is anticipated that it will [...] ients will take part in this study. All will be enrolled at M. D.MD Anderson.
2013-04-16
Study Status v14
Primary completion date2014-04→2015-04
2012-10-16
Study Status, Study Description, Arms and Interventions v13
Study description-4 characters
[...] u will be asked to come in for study follow-up visits every 6 monthsyear, until the study is completed. At these visits, you will ha [...]
2012-06-21
Study Status, Study Design v12
Re-verified, no change to tracked fields
2011-12-20
Study Status, Sponsor/Collaborators, Contacts/Locations v11
Primary completion date2012-04→2014-04
Study sitescontacts updated at 1 of 1 site
2011-08-17
Study Status, Study Description, Study Design, Eligibility v10
Enrollment target70→15
Eligibility criteria-1 characters
Inclusion Criteria: Pathologically confirmed Grade 1-3 chondrosarcoma of the skull base Contrast enhanced post-oppostop MRI or CT if there is clinical contraindication for MRI of [...]
Study descriptionrevised
[...] t are approved by the FDA for patient use. A total of up to 7015 patients will take part in this study. All will be enrolled at M. D. Anderson.
2011-03-30
Study Status v9
Primary completion date2011-04→2012-04
2010-11-15
Study Status, Study Description, Contacts/Locations v8
Study description-657 characters
[...] thology 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 t [...] If you are found to be eligible to take part in this study, [...] and its treatment are approved by the FDA for patient use. The cost of the proton therapy will be billed to you and/or your insurance company. The charge for proton treatment may [...] [...]
Study sites1 entry, revised
U.T.M.D.UT MD Anderson Cancer Center
2010-06-07
Study Status, Study Description v7
Study description+312 characters
[...] uston. 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 v [...] and its treatment are approved by the FDA for patient use. The cost of the proton therapy will be billed to you and/or your insurance company. The charge for proton treatment may be as much as $50,000, billed to your insurance company. A total of up to 70 patients will take part in this study. All will be enrolled at M. D [...]
2009-12-02
Study Status, Outcome Measures v6
Primary endpoints1 entry, revised
ToTime learnto Local Recurrence (local recurrence defined as progression on MRI or CT if proton beam therapyMRI is effective in the treatment of skull base chondrosarcoma.contraindicated)
2009-06-02
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility v5
Eligibility criteria+60 characters
Inclusion Criteria: Pathologically confirmed Grade 1-3 chondrosarcoma of the skull base Contrast enhanced post-op MRI or CT if there is clinical contraindication for MRI of the skull base obtained with 3090 days of study registration at M. D. Anderson The patient ha [...]
Secondary endpoints-38 characters
To study the safety of this treatment.
2008-12-09
Study Status, Study Description v4
Re-verified, no change to tracked fields
2008-10-31
Study Status, Outcome Measures v3
Primary completion date2009-04→2011-04
Completion date2009-04→not stated
Secondary endpoints2 to 1 entries
DetermineTo study the patternssafety of failurethis of skull base chondrosarcoma treated with surgery and proton beam therapytreatment. Measure and characterize the late effects of proton therapy using longitudinal neuropsychological, neuro-endocrine, neuro-ophthalmological and neuro-otologic testing.
Primary endpoints1 entry, revised
EstablishTo thelearn efficacy ofif proton beam therapy foris effective in the treatment of skull base chondrosarcoma.
2008-08-21
Study Status, Study Description, References v2
Study description-177 characters
[...] and its treatment are approved by the FDA for patient use. The cost of the proton therapy will be billed to you and/or your insurance company. The charge for proton treatment may be as much as $50,000, billed to your insurance company. A total of up to 70 patients will take part in this study. All will be enrolled at M. D. Anderson.
2008-01-03
Study Status, Sponsor/Collaborators, Arms and Interventions, Outcome Measures v1
Primary completion datenot stated→2009-04
Completion datenot stated→2009-04
Study arms0→1
2007-07-02
Original filing
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.
Trial Details
NCT Number NCT00496522
Lead Sponsor M.D. Anderson Cancer Center
Conditions Chondrosarcoma
Enrollment 15 participants
Start Date 2006-04-28
Primary Completion 2028-08-19 (estimated)
Study Completion 2028-08-19 (estimated)
Updated on ClinicalTrials.gov 2026-09-29