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Active, Not Recruiting

NCT Number: NCT00496522

Proton Beam Therapy for Chondrosarcoma

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proton Beam Therapy

Procedure

A total dose of up to 70 CGE given at 2.0 CGE per daily fraction for 35 fractions.

Primary outcomes

  1. Time to Local Recurrence

    Time frame: Baseline to local recurrence (evaluation every six months during estimated 5 year study)

    Local recurrence defined as progression on magnetic resonance imaging (MRI) or CT if MRI is contraindicated.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

Phase II Evaluation of Proton Beam Therapy for Skull Base Chondrosarcoma

Important dates

Study start
2006
Primary completion
2026
Study completion
2026
First posted
Jul 4, 2007
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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