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Proton Beam Therapy for Chondrosarcoma

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

Amendment history

  1. Notable

    Primary and study completion pushed from Aug 19, 2026 to Aug 19, 2028

    Eligibility criteria expanded, about 7 words

    Show what changed: Eligibility 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 cont [...] tained 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

  2. Minor

    4 amendments

    4 re-verifications since 2024-09-13, no change to tracked fields

    v32-v35

  3. Notable

    Primary and study completion dates: Aug 19, 2024 to Aug 19, 2026

    Study Status, Oversightv31

  4. Minor

    3 amendments

    3 re-verifications since 2023-02-24, no change to tracked fields

    v28-v30

  5. Minor

    Start date: Apr 2006 to Apr 28, 2006

    Study Statusv27

Show 25 earlier versions

  1. Minor

    Study site revised

    Show what changed: Study sites
    University of Texas MD Anderson Cancer Center

    Study Identification, Study Status, Contacts/Locations, Referencesv26

  2. Minor

    Study Status, Study Design

    Re-verified, no change to tracked fields

    v25

  3. Notable

    Primary and study completion dates: Apr 2019 to Aug 19, 2024

    Study Statusv24

  4. Minor

    Study Status

    Re-verified, no change to tracked fields

    v23

  5. Notable

    Primary completion date: Apr 2017 to Apr 2019

    Completion date: Apr 2019

    Study Status, Oversight, Outcome Measuresv22

  6. Minor

    Study Status

    Re-verified, no change to tracked fields

    v21

  7. Notable

    Primary completion date: Apr 2016 to Apr 2017

    Study site revised

    Show what changed: Study sites
    UTUniversity of Texas MD Anderson Cancer Center

    Study Status, Contacts/Locationsv20

  8. Notable

    Primary completion date: Apr 2015 to Apr 2016

    Trial status: Recruiting to Active, Not Recruiting; Site details revised

    Study Identification, Study Status, Contacts/Locations, Referencesv19

  9. Notable

    Primary endpoint revised

    Show what changed: Primary endpoints
    Time to Local Recurrence (local recurrence defined as progression on MRI or CT if MRI is contraindicated)

    Study Status, Outcome Measuresv18

  10. Minor

    Study Status

    Re-verified, no change to tracked fields

    v17

  11. Minor

    Study description shortened, about 2 words

    Show what changed: Study description
    [...] 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.

    Study Status, Study Descriptionv16

  12. Notable

    Primary completion date: Apr 2014 to Apr 2015

    Study Statusv15

  13. Minor

    Study description shortened, about 1 word

    Show what changed: Study description
    [...] 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 [...]

    Study Status, Study Description, Arms and Interventionsv14

  14. Minor

    Study Status, Study Design

    Re-verified, no change to tracked fields

    v13

  15. Notable

    Primary completion date: Apr 2012 to Apr 2014

    Site contact updated

    Study Status, Sponsor/Collaborators, Contacts/Locationsv12

  16. Notable

    Enrollment target: 70 to 15

    Eligibility criteria revised; Study description revised

    Show what changed: Eligibility criteria
    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 [...]
    Show what changed: Study description
    [...] 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.

    Study Status, Study Description, Study Design, Eligibilityv11

  17. Notable

    Primary completion date: Apr 2011 to Apr 2012

    Study Statusv10

  18. Minor

    Study description shortened, about 115 words

    Study site revised

    Show what changed: Study description
    [...] 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 [...] [...]
    Show what changed: Study sites
    U.T.M.D.UT MD Anderson Cancer Center

    Study Status, Study Description, Contacts/Locationsv9

  19. Minor

    Study description expanded, about 53 words

    Show what changed: Study description
    [...] 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 [...]

    Study Status, Study Descriptionv8

  20. Notable

    Primary endpoint revised

    Show what changed: Primary endpoints
    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)

    Study Status, Outcome Measuresv7

  21. Minor

    Eligibility criteria expanded, about 10 words

    Secondary endpoints shortened, about 7 words

    Show what changed: Eligibility criteria
    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 [...]
    Show what changed: Secondary endpoints
    To study the safety of this treatment.

    Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibilityv6

  22. Minor

    Study Status, Study Description

    Re-verified, no change to tracked fields

    v5

  23. Notable

    Primary completion date: Apr 2009 to Apr 2011

    Primary endpoint revised; Completion date: Apr 2009 to not stated; Secondary endpoints: 2 to 1

    Show what changed: Primary endpoints
    EstablishTo thelearn efficacy ofif proton beam therapy foris effective in the treatment of skull base chondrosarcoma.
    Show what changed: Secondary endpoints
    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.

    Study Status, Outcome Measuresv4

  24. Minor

    Study description shortened, about 31 words

    Show what changed: Study description
    [...] 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.

    Study Status, Study Description, Referencesv3

  25. Minor

    Primary and study completion dates: Apr 2009

    Study arms: 0 to 1

    Study Status, Sponsor/Collaborators, Arms and Interventions, Outcome Measuresv2

  1. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov